Identity
- Trade Name
- Small Tear replaces Stryker® FDA UDI
- Generic Name
- Bone file/rasp, reciprocating, single-use FDA UDI
- Model / Reference
- TM5511RS FDA UDI
Identifiers
- Catalog Number
- TM5511RS FDA UDI
- Primary DI / UDI-DI
- 14053613294529 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Bone file/rasp, reciprocating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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: Bone file/rasp, reciprocating, single-use
Small Tear replaces Stryker® by Gebr. Brasseler GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone file/rasp, reciprocating, single-use.
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
- BONE FILE #64X CROSS CUT HD D/E — W.H. Holden, Inc. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- BONE FILE #52X CROSS CUT HF D/E — W.H. Holden, Inc. · Class I
- BONE FILE #52X CROSS CUT HD D/E — W.H. Holden, Inc. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- BONE FILE WAHL 1W SINGLE CUT HD D/E — W.H. Holden, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Gebr. Brasseler GmbH & Co. KG
Sources (1)
- FDA UDI 94d55451-2cbe-4e77-a6d2-652db863719b 33 fields · synced Jun 8, 2026