Pilling
Titanium Pediatric Sternal Spreader, 52 Millimeter Blades
34manufacturers in China registered for this device type
394catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2026-02-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Width 2 to 351 mm; length 7.5 to 36.5 cm; length 25 to 530 mm; width 0.375 to 4.26 in; depth 17 to 315 mm; length 2.35 to 26 in; angle 90 °; width 2.1 to 17 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN017309 | In distribution | ||
| IPN005110 | Width 2.23 in | In distribution | |
| IPN017242 | In distribution | ||
| IPN003531 | Length 20 cm | In distribution | |
| IPN022085 | In distribution | ||
| IPN005120 | Width 200 mm | In distribution | |
| IPN003511 | Length 11.7 cm | In distribution | |
| IPN017141 | In distribution | ||
| IPN003772 | Length 190 mm | In distribution | |
| IPN003741 | Width 25 mm | In distribution | |
| IPN912018 | In distribution | ||
| IPN017258 | In distribution | ||
| IPN017214 | In distribution | ||
| IPN017387 | In distribution | ||
| IPN022087 | In distribution | ||
| IPN017260 | In distribution | ||
| IPN017223 | In distribution | ||
| IPN003579 | Width 1.7 in | 2 | In distribution |
| IPN017246 | In distribution | ||
| IPN003535 | Width 40 mm | In distribution | |
| IPN021648 | In distribution | ||
| IPN003802 | Length 160 mm | In distribution | |
| IPN003754 | Width 38 mm | In distribution | |
| IPN019990 | In distribution | ||
| IPN017254 | In distribution | ||
| IPN924089 | In distribution | ||
| IPN003766 | Length 195 mm | In distribution | |
| IPN005072 | Length 300 mm | In distribution | |
| IPN007741 | Length 10 in | In distribution | |
| IPN003780 | In distribution | ||
| IPN007587 | Length 19.7 cm | In distribution | |
| IPN003521 | Length 21.5 cm | In distribution | |
| IPN019985 | In distribution | ||
| IPN019988 | In distribution | ||
| IPN017261 | In distribution | ||
| IPN003663 | 5-6 | In distribution | |
| IPN005072 | Length 300 mm | In distribution | |
| IPN003740 | Length 390 mm | In distribution | |
| IPN007028 | Length 18 cm | In distribution | |
| IPN007602 | Length 33 cm | In distribution | |
| IPN020002 | In distribution | ||
| IPN005115 | Width 74 mm | In distribution | |
| IPN007601 | Length 32.5 cm | In distribution | |
| IPN003760 | Angle 90 ° | In distribution | |
| IPN005111 | Width 2.23 in | In distribution | |
| IPN056046 | In distribution | ||
| IPN924084 | In distribution | ||
| IPN911944 | In distribution | ||
| IPN017277 | In distribution | ||
| IPN003548 | Length 22.5 cm | In distribution | |
| IPN924095 | In distribution | ||
| IPN017262 | In distribution | ||
| IPN017155 | In distribution | ||
| IPN019971 | In distribution | ||
| IPN003742 | Length 110 mm | In distribution | |
| IPN017341 | In distribution | ||
| IPN007597 | Depth 5 cm | In distribution | |
| IPN019998 | In distribution | ||
| IPN003764 | Width 50 mm | In distribution | |
| IPN017288 | In distribution | ||
| IPN017171 | In distribution | ||
| IPN004670 | Length 32.8 cm | In distribution | |
| IPN003774 | Depth 260 mm | In distribution | |
| IPN017282 | In distribution | ||
| IPN003551 | Width 26.2 mm | In distribution | |
| IPN003519 | Length 22 cm | In distribution | |
| IPN003540 | Width 20.5 mm | In distribution | |
| IPN005103 | Length 286 mm | In distribution | |
| IPN017397 | In distribution | ||
| IPN020010 | In distribution | ||
| IPN017243 | In distribution | ||
| IPN055985 | In distribution | ||
| IPN007026 | Length 15.5 cm | In distribution | |
| IPN003664 | 7-8 | In distribution | |
| IPN005144 | Length 24 cm | In distribution | |
| IPN005116 | Width 100 mm | In distribution | |
| IPN002094 | Length 4.25 in | In distribution | |
| IPN007583 | Length 18.7 cm | In distribution | |
| IPN003744 | Length 483 mm | In distribution | |
| IPN003536 | Length 24.5 cm | In distribution | |
| IPN017279 | In distribution | ||
| IPN003547 | Length 22.5 cm | In distribution | |
| IPN003561 | Length 15.5 cm | In distribution | |
| IPN003748 | Angle 90 ° | In distribution | |
| IPN017240 | In distribution | ||
| IPN017212 | In distribution | ||
| IPN005435 | Length 19 cm | In distribution | |
| IPN007564 | Length 18.1 cm | In distribution | |
| IPN007558 | Length 10.5 cm | In distribution | |
| IPN017339 | In distribution | ||
| IPN002717 | In distribution | ||
| IPN005155 | Length 26 cm | In distribution | |
| IPN005110 | Width 2.23 in | In distribution | |
| IPN005121 | Length 284 mm | In distribution | |
| IPN005109 | Width 72 mm | In distribution | |
| IPN003526 | Length 20 cm | In distribution | |
| IPN003503 | Length 13 in | In distribution | |
| IPN002260 | Length 16.5 cm | In distribution | |
| IPN003499 | Width 25 mm | In distribution | |
| IPN007596 | Width 15.5 cm | In distribution | |
| IPN055984 | In distribution | ||
| IPN017150 | In distribution | ||
| IPN019958 | In distribution | ||
| IPN003797 | Length 505 mm | In distribution | |
| IPN017183 | In distribution | ||
| IPN017218 | In distribution | ||
| IPN003873 | In distribution | ||
| IPN003508 | Width 3 in | In distribution | |
| IPN019556 | In distribution | ||
| IPN017122 | In distribution | ||
| IPN003532 | Length 22.5 cm | In distribution | |
| IPN005114 | Width 1.45 in | In distribution | |
| IPN017166 | In distribution | ||
| IPN928883 | In distribution | ||
| IPN003788 | Length 245 mm | In distribution | |
| IPN019668 | In distribution | ||
| IPN003762 | Depth 75 mm | In distribution | |
| IPN005114 | Width 1.45 in | In distribution | |
| IPN005121 | Width 223 mm | In distribution | |
| IPN003512 | Length 11.7 cm | In distribution | |
| IPN005117 | Length 83 mm | In distribution | |
| IPN003523 | Length 21.9 cm | In distribution | |
| IPN005091 | Width 222 mm | In distribution | |
| IPN003781 | Depth 72 mm | In distribution | |
| IPN003769 | Length 195 mm | In distribution | |
| IPN927420 | In distribution | ||
| IPN005112 | Width 4.26 in | In distribution | |
| IPN003520 | Length 21.9 cm | In distribution | |
| IPN007570 | Length 15 cm | In distribution | |
| IPN019968 | In distribution | ||
| IPN017290 | In distribution | ||
| IPN017289 | In distribution | ||
| IPN003874 | In distribution | ||
| IPN017563 | In distribution | ||
| IPN003753 | Length 340 mm | In distribution | |
| IPN017172 | In distribution | ||
| IPN004671 | Length 31.2 cm | In distribution | |
| IPN007561 | Length 16.3 cm | In distribution | |
| IPN003537 | Length 25.5 cm | In distribution | |
| IPN003756 | Width 50 mm | In distribution | |
| IPN003524 | Length 22 cm | In distribution | |
| IPN017217 | In distribution | ||
| IPN005123 | Width 146 mm | In distribution | |
| IPN017186 | In distribution | ||
| IPN003501 | Width 50.5 mm | In distribution | |
| IPN020007 | In distribution | ||
| IPN002095 | 3 x 3 prongs | In distribution | |
| IPN003747 | Length 25 mm | In distribution | |
| IPN017209 | In distribution | ||
| IPN003533 | Length 22.5 cm | In distribution | |
| IPN003794 | Length 353 mm | In distribution | |
| IPN003784 | Width 95 mm | In distribution | |
| IPN003522 | Length 21.5 cm | In distribution | |
| IPN017169 | In distribution | ||
| IPN017299 | In distribution | ||
| IPN003560 | Width 6.5 mm | In distribution | |
| IPN005113 | Length 6.46 in | In distribution | |
| IPN017560 | In distribution | ||
| IPN020097 | In distribution | ||
| IPN005144 | Length 24 cm | In distribution | |
| IPN005156 | Length 31.5 cm | In distribution | |
| IPN907049 | In distribution | ||
| IPN003495 | Width 26 mm | In distribution | |
| IPN002094 | Length 4.25 in | In distribution | |
| IPN056045 | In distribution | ||
| IPN007565 | Length 19.2 cm | In distribution | |
| IPN003549 | Length 22.5 cm | In distribution | |
| IPN005104 | Width 230 mm | In distribution | |
| IPN005105 | Length 216 mm | In distribution | |
| IPN019973 | In distribution | ||
| IPN056113 | In distribution | ||
| IPN003546 | Length 21.4 cm | In distribution | |
| IPN003496 | Width 25.5 mm | In distribution | |
| IPN005107 | Width 99 mm | In distribution | |
| IPN019555 | In distribution | ||
| IPN020012 | In distribution | ||
| IPN022630 | Width 3 mm | In distribution | |
| IPN007563 | Length 17.9 cm | In distribution | |
| IPN017196 | In distribution | ||
| IPN005109 | Width 72 mm | In distribution | |
| IPN005423 | Length 18.5 cm | In distribution | |
| IPN003517 | Width 0.375 in | In distribution | |
| IPN003758 | Angle 90 ° | In distribution | |
| IPN003515 | Length 11.5 cm | In distribution | |
| IPN017325 | In distribution | ||
| IPN003557 | Length 15 cm | 2 | In distribution |
| IPN005107 | Width 99 mm | In distribution | |
| IPN003504 | Width 1.25 in | In distribution | |
| IPN003541 | Length 24.5 cm | In distribution | |
| IPN003518 | Width 13.5 mm | In distribution | |
| IPN003751 | Angle 90 ° | In distribution | |
| IPN017337 | In distribution | ||
| IPN022449 | In distribution | ||
| IPN007589 | Length 24.1 cm | In distribution | |
| IPN003796 | Length 415 mm | In distribution | |
| IPN003752 | Angle 90 ° | In distribution | |
| IPN017259 | In distribution | ||
| IPN005123 | Width 146 mm | In distribution | |
| IPN003800 | Length 530 mm | In distribution | |
| IPN019984 | In distribution | ||
| IPN003798 | Length 390 mm | In distribution | |
| IPN017342 | In distribution | ||
| IPN924090 | In distribution | ||
| IPN003875 | In distribution | ||
| IPN003747 | Length 25 mm | In distribution | |
| IPN003538 | Length 26.5 cm | In distribution | |
| IPN005433 | Length 18.5 cm | In distribution | |
| IPN924067 | In distribution | ||
| IPN007584 | Length 19.2 cm | In distribution | |
| IPN005434 | Length 19 cm | In distribution | |
| IPN003527 | Width 29 mm | In distribution | |
| IPN017278 | In distribution | ||
| IPN017914 | In distribution | ||
| IPN003558 | Height 1.6 cm | 2 | In distribution |
| IPN003497 | Width 25.5 mm | In distribution | |
| IPN007739 | Length 26 in | In distribution | |
| IPN007626 | Length 22.5 cm | In distribution | |
| IPN003765 | Width 50 mm | In distribution | |
| IPN007574 | Length 21.9 cm | In distribution | |
| IPN003502 | Length 30.5 cm | In distribution | |
| IPN003789 | Depth 114 mm | In distribution | |
| IPN017140 | In distribution | ||
| IPN003553 | Width 48 mm | In distribution | |
| IPN017224 | In distribution | ||
| IPN022629 | Depth 180 mm | In distribution | |
| IPN003505 | Width 1.5 in | In distribution | |
| IPN003792 | Width 215 mm | In distribution | |
| IPN017392 | In distribution | ||
| IPN007586 | Length 19.5 cm | In distribution | |
| IPN005106 | Width 65 mm | In distribution | |
| IPN022088 | In distribution | ||
| IPN017253 | In distribution | ||
| IPN017211 | In distribution | ||
| IPN003498 | Width 25 mm | In distribution | |
| IPN005113 | Length 6.46 in | In distribution | |
| IPN003507 | Width 2.5 in | In distribution | |
| IPN006335 | Length 7.5 cm | In distribution | |
| IPN003564 | Length 17.5 cm | In distribution | |
| IPN005053 | In distribution | ||
| IPN019552 | In distribution | ||
| IPN003749 | Depth 103 mm | In distribution | |
| IPN017174 | In distribution | ||
| IPN003777 | Length 210 mm | In distribution | |
| IPN017202 | In distribution | ||
| IPN003559 | Length 16 cm | In distribution | |
| IPN020564 | In distribution | ||
| IPN007588 | Length 24.1 cm | In distribution | |
| IPN017168 | In distribution | ||
| IPN005154 | Length 19.5 cm | In distribution | |
| IPN007024 | Width 6.4 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-05-25 | Class II | Other | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | 170 units |
| 2023-05-25 | Class II | Other | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | 32 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.