Identity
- Trade Name
- PM 1124 46mm FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Model / Reference
- 1600612 FDA UDI
Identifiers
- Catalog Number
- 1600612-001 FDA UDI
- Primary DI / UDI-DI
- 07630055505538 FDA UDI
- 510(k) Number
- K792159 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Drilling power tool attachment, basic
PM 1124 46mm by Bien-Air Surgery SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drilling power tool attachment, basic.
- Smith and Nephew — Provision · Class I
- Stryker — Provision · Class I
- Treace Medical Concepts — Provision · Class I
- Synthes — Provision · Class I
- Treace Medical Concepts — Provision · Class I
- GEO — Provision · Class I
- Synthes — Provision · Class I
- CrossRoads — Provision · Class I
Cleared under the same submission
K792159 also covers:
- BASCH Micromotor — Bien-Air Surgery SA
- BASCH Micromotor + Cable — Bien-Air Surgery SA
- BASCH Micromotor + Cable — Bien-Air Surgery SA
- BASCH-1 Micromotor — Bien-Air Surgery SA
- BASCH-1 Micromotor + Cable — Bien-Air Surgery SA
- OSSEODOC Control Unit — Bien-Air Surgery SA
- OSSEODOC Control Unit + Pump — Bien-Air Surgery SA
- OSSEODOC Foot Pedal — Bien-Air Surgery SA
- PMAM 1122 125mm — Bien-Air Surgery SA
- PMAM 1122 70mm — Bien-Air Surgery SA
- PMAM 1122 95mm — Bien-Air Surgery SA
- PMAM 1221 125mm — Bien-Air Surgery SA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bien-Air Surgery SA
Sources (1)
- FDA UDI 1fb22674-d9c4-494c-9fa1-2cf3d580d5b9 34 fields · synced May 31, 2026