ACE
Replacement Covers Molt Mouth Gags FOR Child & Adult 2/PKG These ARE NOT Latex Free
53manufacturers in China registered for this device type
190catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Ace Surgical Supply Co., Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| 510(k) | K951392 |
| Record published | 2019-10-13 |
| Record revised | 2022-09-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: No special storage conditions required |
| Sizes | Length 1 to 12 in; length 1.25 to 75 mm; height 2.5 to 7.375 in; length 3.5 to 13 cm; length 10 ft; width 1.5 in; width 3 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00320101 | Length 4.5 cm | In distribution | |
| 0900014 | In distribution | ||
| 0117023 | 2 | In distribution | |
| 0900022 | In distribution | ||
| 0116036 | In distribution | ||
| 0117041 | In distribution | ||
| 0703008 | In distribution | ||
| 0034212 | In distribution | ||
| 0531015 | Height 6.875 in | In distribution | |
| 0900040 | In distribution | ||
| 0031158 | In distribution | ||
| 00320102 | Length 6.5 cm | In distribution | |
| 0034218 | In distribution | ||
| 0900011 | In distribution | ||
| 0034215 | In distribution | ||
| 0531034 | Length 8 in | In distribution | |
| 0531025 | Height 7.25 in | In distribution | |
| 0900041 | In distribution | ||
| 0531026 | Height 4 in | In distribution | |
| 0916118 | 12 | In distribution | |
| 0900015 | In distribution | ||
| 04974702 | Length 36 mm | In distribution | |
| 0531013 | Height 3.25 in | In distribution | |
| 0034044 | In distribution | ||
| 0030004 | In distribution | ||
| 04974002 | Length 36 mm | In distribution | |
| 9600320 | In distribution | ||
| 0900090 | In distribution | ||
| 0034210 | Length 4 in | In distribution | |
| 0900018 | In distribution | ||
| 0032261 | In distribution | ||
| 0918119 | 12 | In distribution | |
| 0600073 | Length 8 in | In distribution | |
| 0032186 | Length 4 mm | In distribution | |
| 0900024 | In distribution | ||
| 6300107 | Length 6 in | In distribution | |
| 0900043 | In distribution | ||
| 0116018 | Length 4.5 in | In distribution | |
| 6300101 | Length 6.5 in | In distribution | |
| 6300111 | Length 7.5 in | In distribution | |
| 6300118 | Length 7.5 in | In distribution | |
| 0116038 | In distribution | ||
| 0117043 | In distribution | ||
| 6462002 | In distribution | ||
| 0030003 | In distribution | ||
| 0531027 | Height 4.4375 in | In distribution | |
| 0900064 | In distribution | ||
| 20165001 | In distribution | ||
| 0900019 | In distribution | ||
| 04974101 | Length 27 mm | In distribution | |
| 0911072 | In distribution | ||
| 0032276 | Length 15 mm | In distribution | |
| 04974701 | Length 30 mm | In distribution | |
| 0531010 | Height 3 in | In distribution | |
| 0900021 | In distribution | ||
| 0034215 | Length 10.5 cm | In distribution | |
| 20155411 | Length 14 mm | In distribution | |
| 0100456 | Length 20 mm | In distribution | |
| 0116037 | In distribution | ||
| 0500096 | In distribution | ||
| 0900066 | In distribution | ||
| 0800171 | Length 7 in | In distribution | |
| 6500004 | Length 1.25 mm | In distribution | |
| 9600315 | In distribution | ||
| 6300103 | Length 6.5 in | In distribution | |
| 6462001 | In distribution | ||
| 20155211 | Length 17 mm | In distribution | |
| 0911073 | In distribution | ||
| 6500009 | Length 9 mm | In distribution | |
| 04974502 | Length 36 mm | In distribution | |
| 0800160 | In distribution | ||
| 0900053 | In distribution | ||
| 0900006 | In distribution | ||
| 0030002 | Length 2 in | In distribution | |
| 20155312 | Length 17 mm | In distribution | |
| 0900001 | In distribution | ||
| 6300113 | Length 6.5 in | In distribution | |
| 0100350 | In distribution | ||
| 0900004 | In distribution | ||
| 6834302 | In distribution | ||
| 0039085 | Length 2.25 in | In distribution | |
| 6500008 | Length 1.5 mm | In distribution | |
| 0900016 | In distribution | ||
| 0116035 | In distribution | ||
| 0034210 | In distribution | ||
| 0900005 | In distribution | ||
| 0039089 | In distribution | ||
| 0900010 | In distribution | ||
| 0531033 | Length 6 in | In distribution | |
| 0900211 | Length 5.5 cm | In distribution | |
| 0800170 | Length 8 in | In distribution | |
| 0702042 | Length 2.5 in | In distribution | |
| 0918120 | 12 | In distribution | |
| 0117042 | In distribution | ||
| 6500005 | Length 1.5 mm | In distribution | |
| 59100193 | In distribution | ||
| 0034045 | In distribution | ||
| 0900071 | In distribution | ||
| 0900003 | In distribution | ||
| 0900020 | In distribution | ||
| 20169001 | In distribution | ||
| 6300115 | Length 6.5 in | In distribution | |
| 6300117 | Length 6.5 in | In distribution | |
| 0900030 | In distribution | ||
| 0500074 | Length 10 mm | In distribution | |
| 0900012 | In distribution | ||
| 9600449 | Length 50 mm | In distribution | |
| 9600228 | Length 75 mm | In distribution | |
| 0117016 | Length 5.5 in | In distribution | |
| 0900129 | In distribution | ||
| 0900044 | In distribution | ||
| 0800110 | In distribution | ||
| 04974501 | Length 30 mm | In distribution | |
| 4549250 | Length 18 mm | In distribution | |
| 04974001 | Length 30 mm | In distribution | |
| 9600319 | In distribution | ||
| 0531036 | Length 12 in | In distribution | |
| 34211 | Length 4.25 in | In distribution | |
| 6300122 | Length 7.25 in | In distribution | |
| 0032973 | In distribution | ||
| 0900060 | In distribution | ||
| 6834301 | In distribution | ||
| 0917118 | 12 | In distribution | |
| 04941801 | In distribution | ||
| 0531005 | In distribution | ||
| 0900108 | In distribution | ||
| 0033008 | In distribution | ||
| 6400305 | In distribution | ||
| 0032185 | In distribution | ||
| 6300124 | Length 7.25 in | In distribution | |
| 6300123 | Length 7.25 in | In distribution | |
| 05560000 | In distribution | ||
| 00320104 | Length 10 ft | In distribution | |
| 0900202 | In distribution | ||
| 8372160 | Length 11 in | In distribution | |
| 0531014 | Height 5.25 in | In distribution | |
| 6300129 | Length 7.25 in | In distribution | |
| 9600448 | In distribution | ||
| 0034010 | In distribution | ||
| 0034205 | In distribution | ||
| 0531016 | Height 7.375 in | In distribution | |
| 0900032 | In distribution | ||
| 0900017 | In distribution | ||
| 0034212 | Length 9 cm | In distribution | |
| 0900035 | In distribution | ||
| 1102006 | In distribution | ||
| 6300114 | Length 6.5 in | In distribution | |
| 0531008 | Length 3 in | In distribution | |
| 0900002 | In distribution | ||
| 0900062 | In distribution | ||
| 0900087 | In distribution | ||
| 0900033 | In distribution | ||
| 0900023 | In distribution | ||
| 04941301 | In distribution | ||
| 9600316 | In distribution | ||
| 1128004 | In distribution | ||
| 0900036 | In distribution | ||
| 0900212 | In distribution | ||
| 6300104 | Length 6.5 in | In distribution | |
| 0800172 | Length 7.75 in | In distribution | |
| 0034243 | Length 7.5 in | In distribution | |
| 0916117 | 12 | In distribution | |
| 0100448 | Length 10 mm | In distribution | |
| 0911074 | In distribution | ||
| 00320125 | Length 10 ft | In distribution | |
| 0531035 | Length 10 in | In distribution | |
| 0900070 | In distribution | ||
| 0900050 | In distribution | ||
| 0030001 | Length 1 in | In distribution | |
| 20155311 | Length 13 mm | In distribution | |
| 0900038 | In distribution | ||
| 4811001 | In distribution | ||
| 6300125 | Length 7.25 in | In distribution | |
| 0100152 | 2 | In distribution | |
| 0100025 | Length 5 in | In distribution | |
| 0917119 | 12 | In distribution | |
| 0531009 | Height 2.5 in | In distribution | |
| 3440301 | In distribution | ||
| 0900063 | In distribution | ||
| 6500007 | Length 1.25 mm | In distribution | |
| 8372161 | Length 7 in | In distribution | |
| 0531007 | In distribution | ||
| 6200097A | Length 6.5 in | In distribution | |
| 0800177 | Length 6 in | In distribution | |
| 0116040 | In distribution | ||
| 0531006 | In distribution | ||
| 0900065 | In distribution | ||
| 0900042 | In distribution | ||
| 0116039 | In distribution | ||
| 0100450 | Length 6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
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.