Identity
- Trade Name
- Aesculap FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Model / Reference
- AA804R FDA UDI
Identifiers
- Primary DI / UDI-DI
- B504GSAA804R0 FDA UDI
- FDA Product Code
- KDC FDA UDI
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Drilling power tool attachment, basic
Aesculap by Provision — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drilling power tool attachment, basic.
- Made-To-Order — TORNIER, INC. · Class I
- Primado2 — NAKANISHI INC. · Class II
- HS-Handpiece, angled, 125mm, 80k — Bien-Air Surgery SA · Class II
- Made-To-Order — TORNIER, INC. · Class I
- TMC PSI Cut Guide System — TREACE MEDICAL CONCEPTS, INC. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Tornier Perform — TORNIER, INC. · Class I
- Primado2 — NAKANISHI INC. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Provision
Sources (1)
- FDA UDI 93e71878-fe4b-47aa-8e09-2bfaf33cabd5 33 fields · synced Jun 1, 2026