Identity
- Trade Name
- Washer, OD=16/25mm, ID=9mm FDA UDI
- Generic Name
- Orthopaedic bone washer, sterile FDA UDI
- Model / Reference
- 36851 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120069818086 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic bone washer, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone washer, sterile
Washer, OD=16/25mm, ID=9mm by I.T.S. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone washer, sterile.
- BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- FLAT WASHER6.5MM — Biomet Orthopedics, Inc. · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- RONDO' — Citieffe · Class II
- SURFIX — Newdeal Sas · Class II
- SURFIX — Newdeal Sas · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- I.T.S. GmbH
Sources (1)
- FDA UDI 95e321df-dc84-4ab7-8808-4aabd1632d7f 32 fields · synced Jun 8, 2026