Pilling
Spatula Retractor Pediatric Right
3manufacturers in China registered for this device type
90catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-15 |
| Record revised | 2026-07-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 12 to 54.1 cm; width 4 to 92 mm; length 168 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN008121 | Length 32.5 cm | In distribution |
| IPN017265 | In distribution | |
| IPN002255 | Length 16 cm | In distribution |
| IPN008121 | Width 8 mm | In distribution |
| IPN021645 | In distribution | |
| IPN002239 | Length 12 cm | In distribution |
| IPN002091 | Width 9.5 mm | In distribution |
| IPN008255 | Length 17.5 cm | In distribution |
| IPN021655 | In distribution | |
| IPN008123 | Length 31.5 cm | In distribution |
| IPN021644 | In distribution | |
| IPN002250 | Length 13 cm | In distribution |
| IPN002386 | Length 22 cm | In distribution |
| IPN008258 | Length 16.8 cm | In distribution |
| IPN021636 | In distribution | |
| IPN008123 | Length 31.5 cm | In distribution |
| IPN008125 | Length 32.5 cm | In distribution |
| IPN022027 | In distribution | |
| IPN002246 | Length 15.9 cm | In distribution |
| IPN002254 | Length 16 cm | In distribution |
| IPN002252 | Length 18 cm | In distribution |
| IPN002257 | Length 19 cm | In distribution |
| IPN002249 | Length 16.5 cm | In distribution |
| IPN021653 | In distribution | |
| IPN021650 | In distribution | |
| IPN002371 | Length 13.7 cm | In distribution |
| IPN002244 | Length 15.9 cm | In distribution |
| IPN008259 | Width 9 mm | In distribution |
| IPN002253 | Length 12.5 cm | In distribution |
| IPN008257 | Length 17.6 cm | In distribution |
| IPN002262 | Length 13.5 cm | In distribution |
| IPN008263 | Length 16.8 cm | In distribution |
| IPN002362 | Width 92 mm | In distribution |
| IPN002415 | Length 23 cm | In distribution |
| IPN002380 | Length 15.5 cm | In distribution |
| IPN008262 | Length 16.8 cm | In distribution |
| IPN002263 | Length 168 mm | In distribution |
| IPN008125 | Width 10 mm | In distribution |
| IPN008124 | Length 32.5 cm | In distribution |
| IPN021652 | In distribution | |
| IPN007050 | Length 23 cm | In distribution |
| IPN002379 | Length 15.5 cm | In distribution |
| IPN907050 | In distribution | |
| IPN021983 | In distribution | |
| IPN021641 | In distribution | |
| IPN002261 | Length 14.5 cm | In distribution |
| IPN002414 | Length 23 cm | In distribution |
| IPN021654 | In distribution | |
| IPN006422 | Length 54.1 cm | In distribution |
| IPN021164 | In distribution | |
| IPN021981 | In distribution | |
| IPN002258 | Length 16 cm | In distribution |
| IPN021167 | In distribution | |
| IPN002251 | Length 18.7 cm | In distribution |
| IPN017412 | In distribution | |
| IPN021168 | In distribution | |
| IPN017413 | In distribution | |
| IPN021172 | In distribution | |
| IPN021635 | In distribution | |
| IPN008124 | Length 32.5 cm | In distribution |
| IPN002378 | Length 15.5 cm | In distribution |
| IPN021163 | In distribution | |
| IPN008126 | Width 5 mm | In distribution |
| IPN002245 | Length 15.9 cm | In distribution |
| IPN008265 | Length 16.8 cm | In distribution |
| IPN002377 | Length 15.5 cm | In distribution |
| IPN008261 | Width 15 mm | In distribution |
| IPN021632 | In distribution | |
| IPN017264 | In distribution | |
| IPN002074 | Length 17.8 cm | In distribution |
| IPN021649 | In distribution | |
| IPN021631 | In distribution | |
| IPN002150 | Length 19.5 cm | In distribution |
| IPN021651 | In distribution | |
| IPN002256 | Length 15.5 cm | In distribution |
| IPN002247 | Length 15.6 cm | In distribution |
| IPN008122 | Width 4 mm | In distribution |
| IPN002238 | Length 12 cm | In distribution |
| IPN002358 | Length 18 cm | In distribution |
| IPN002387 | Width 70 mm | In distribution |
| IPN008126 | Width 5 mm | In distribution |
| IPN021633 | In distribution | |
| IPN002248 | Length 14.8 cm | In distribution |
| IPN002243 | Length 15.5 cm | In distribution |
| IPN008120 | Width 8 mm | In distribution |
| IPN008122 | Width 4 mm | In distribution |
| IPN008264 | Length 16.8 cm | In distribution |
| IPN021165 | In distribution | |
| IPN022026 | In distribution | |
| IPN008120 | Width 8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Fentex | Fentex medical GmbH | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Aesculap | Aesculap AG | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 42 |
| HNM Medical | HNM Stainless, LLC. | 39 |
Showing 12 of 80. All products under Retractor, Ent
Recalls
1 of these is 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). | 365 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.