Identity
- Trade Name
- 3-in-1 SHAVER™ 5.0mm FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Multi-functional shaver blade, disposable FDA UDI
- Model / Reference
- R-10014 FDA UDI
- Description
- Multi-functional shaver blade, disposable FDA UDI
Identifiers
- Catalog Number
- R-10014 FDA UDI
- Primary DI / UDI-DI
- 00859273007144 FDA UDI
- 510(k) Number
- K162770 FDA UDI
- FDA Product Code
- HRX FDA UDIGEI FDA UDI
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI878.4400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.0 Millimeter FDA UDI
Category: Orthopaedic bur, single-useEndoscopic electrosurgical electrode, bipolar, single-useArthroscopic shaver system blade, single-use
3-in-1 SHAVER™ 5.0mm by RELIGN Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic shaver system blade, single-use.
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- VOLMED BRASIL — VOLMED BRASIL EQUIPAMENTOS LTDA · Class I
- SharkCut — Techcord co., Ltd · Class I
Cleared under the same submission
K162770 also covers:
- 3-in-1 SHAVER™ 4.2mm — RELIGN Corporation
- Curved Standard Shaver 3.4mm — RELIGN Corporation
- Dynablator™ — RELIGN Corporation
- Exoflow™ — RELIGN Corporation
- Standard Burr 5.0mm — RELIGN Corporation
- Standard Shaver 3.4mm — RELIGN Corporation
- Tricera™ Controller — RELIGN Corporation
- Tricera™ Handpiece, Autoclavable — RELIGN Corporation
- Veriflow™ — RELIGN Corporation
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 |
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Manufacturer
- Manufacturer
- RELIGN Corporation
Sources (1)
- FDA UDI bf57cc50-261a-49f1-97dd-817ca69fde06 37 fields · synced Jun 9, 2026