MicroAire®
SST TAP, 3.5mm Dia,X-LONG, 2.5mm DRILL, 3.5mm SCREW
27manufacturers in China registered for this device type
75catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (12), Shanghai (5), Guangdong (4). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| 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 Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 27. All 27 manufacturers in China registered for Bit, Drill
Record
| Listed by | Microaire Surgical Instruments LLC, United States |
|---|---|
| FDA product code | HTW |
| Device type | Bit, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-17 |
| Record revised | 2022-09-16 (version 3) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 1.1 to 6.4 mm; length 20 to 170 mm |
| Distribution end date | 2022-03-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8054-016 | Outer Diameter 4 mm | In distribution |
| 8054-010NS | Outer Diameter 1.6 mm | In distribution |
| 8054-018 | Outer Diameter 4.8 mm | In distribution |
| 8054-017 | Outer Diameter 4.5 mm | In distribution |
| 8054-016NS | Outer Diameter 4 mm | In distribution |
| 8054-022 | Outer Diameter 3.2 mm | In distribution |
| 8051-020 | Outer Diameter 2 mm | In distribution |
| 8054-010 | Outer Diameter 1.6 mm | In distribution |
| 8051-027 | Outer Diameter 2.7 mm | In distribution |
| 8054-013 | Outer Diameter 2.8 mm | In distribution |
| 8053-026 | Outer Diameter 2.7 mm | In distribution |
| 8053-044 | Outer Diameter 4.5 mm | In distribution |
| 8054-013NS | Outer Diameter 2.8 mm | In distribution |
| 8053-035NS | Outer Diameter 3.5 mm | In distribution |
| 8053-016 | Outer Diameter 1.5 mm | In distribution |
| 8053-029 | Outer Diameter 3.2 mm | In distribution |
| 8053-025NS | Outer Diameter 2.5 mm | In distribution |
| 8054-012 | Outer Diameter 2.4 mm | In distribution |
| 8053-048 | Outer Diameter 4.5 mm | In distribution |
| 8054-015 | Outer Diameter 3.6 mm | In distribution |
| 8053-015 | Outer Diameter 1.5 mm | In distribution |
| 8054-011NS | Outer Diameter 2 mm | In distribution |
| 8054-012NS | Outer Diameter 2.4 mm | In distribution |
| 8053-037 | Outer Diameter 3.5 mm | In distribution |
| 8054-019 | Outer Diameter 6.4 mm | In distribution |
| 8053-011 | Outer Diameter 1.1 mm | In distribution |
| 8053-031 | Outer Diameter 3.2 mm | In distribution |
| 8054-014NS | Outer Diameter 3.2 mm | In distribution |
| 8054-015NS | Outer Diameter 3.6 mm | In distribution |
| 8054-021 | Outer Diameter 2.8 mm | In distribution |
| 8053-020 | Outer Diameter 2 mm | In distribution |
| 8053-026NS | Outer Diameter 2.7 mm | In distribution |
| 8051-015 | Outer Diameter 1.5 mm | In distribution |
| 8054-017NS | Outer Diameter 4.5 mm | In distribution |
| 8054-020 | Outer Diameter 2 mm | In distribution |
| 8053-031NS | Outer Diameter 3.2 mm | In distribution |
| 8054-018NS | Outer Diameter 4.8 mm | In distribution |
| 8053-021NS | Outer Diameter 2 mm | In distribution |
| 8053-019 | Outer Diameter 2 mm | In distribution |
| 8053-044NS | Outer Diameter 4.5 mm | In distribution |
| 8053-028 | Outer Diameter 2.7 mm | In distribution |
| 8053-021 | Outer Diameter 2 mm | In distribution |
| 8053-035 | Outer Diameter 3.5 mm | In distribution |
| 8053-023 | Outer Diameter 2.5 mm | In distribution |
| 8053-025 | Outer Diameter 2.5 mm | In distribution |
| 8054-011 | Outer Diameter 2 mm | In distribution |
| 8053-019NS | Outer Diameter 2 mm | In distribution |
| 8054-014 | Outer Diameter 3.2 mm | In distribution |
| 8051-021 | Outer Diameter 2.2 mm | Withdrawn |
| 8051-020NS | Outer Diameter 2 mm | Withdrawn |
| 8051-120 | Outer Diameter 2 mm | Withdrawn |
| 8053-132 | Outer Diameter 3.5 mm | Withdrawn |
| 8053-134NS | Outer Diameter 4 mm | Withdrawn |
| 8053-133 | Outer Diameter 3.5 mm | Withdrawn |
| 8053-115 | Outer Diameter 1.5 mm | Withdrawn |
| 8053-060 | Outer Diameter 6 mm | Withdrawn |
| 8051-011 | Outer Diameter 1.1 mm | Withdrawn |
| 8054-023 | Outer Diameter 3.6 mm | Withdrawn |
| 8051-035 | Outer Diameter 3.5 mm | Withdrawn |
| 8053-032 | Outer Diameter 3.2 mm | Withdrawn |
| 8053-146 | Outer Diameter 4.5 mm | Withdrawn |
| 8053-126 | Outer Diameter 2.7 mm | Withdrawn |
| 8053-016NS | Outer Diameter 1.5 mm | Withdrawn |
| 8051-127 | Outer Diameter 2.7 mm | Withdrawn |
| 8053-036 | Outer Diameter 3.5 mm | Withdrawn |
| 8051-013 | Outer Diameter 1.3 mm | Withdrawn |
| 8053-132NS | Outer Diameter 3.5 mm | Withdrawn |
| 8051-018 | Outer Diameter 1.8 mm | Withdrawn |
| 8054-024 | Outer Diameter 4.5 mm | Withdrawn |
| 8051-032 | Outer Diameter 3.2 mm | Withdrawn |
| 8053-119 | Outer Diameter 2 mm | Withdrawn |
| 8053-024 | Outer Diameter 2.5 mm | Withdrawn |
| 8053-134 | Outer Diameter 4 mm | Withdrawn |
| 8054-019NS | Outer Diameter 6.4 mm | Withdrawn |
| 8053-148 | Outer Diameter 4.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bit, Drill | Sterilmed, Inc. | 633 |
| Bit, Drill | Synthes Gmbh | 412 |
| Arthrex® | Arthrex, Inc. | 406 |
| Level ONE | KLS-Martin L.P. | 246 |
| Acumed | Acumed LLC | 205 |
| Stryker | Provision | 198 |
| Arthrex | Provision | 186 |
| Tecomet | Tecomet, Inc. | 166 |
| Synthes | Provision | 164 |
| Drill bit | Jeil Medical Corporation | 134 |
| Bit, Drill | AAP Implantate AG | 114 |
| Emerge Medical & Design | Emerge Technologies, Inc. | 110 |
Showing 12 of 1,958. All products under Bit, Drill
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 | Closed |
|---|---|---|---|---|---|
| 2017-05-22 | Class II | Labeling mix-ups | One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) | 42 | 2018-08-29 |
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.