Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Circular 5.0 mm Washer FDA UDI
- Model / Reference
- HR-WA50-S FDA UDI
- Description
- Circular 5.0 mm Washer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378069758 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Implantable bone washer
Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
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- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · 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 |
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Manufacturer
- Manufacturer
- Acumed Llc
Sources (1)
- FDA UDI cca17925-ddb0-4e1d-9113-6db0dbedd118 34 fields · synced May 31, 2026