Identity
- Trade Name
- SharkCut FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Shaver Blade_OD 5.0 WL 128 Oval Burr Stryker Type FDA UDI
- Model / Reference
- OB1650 FDA UDI
- Description
- Shaver Blade_OD 5.0 WL 128 Oval Burr Stryker Type FDA UDI
Identifiers
- Catalog Number
- OB1650 FDA UDI
- Primary DI / UDI-DI
- 08800053401159 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Arthroscopic shaver system blade, 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
No
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
Dimensions & Sizes
- Size
- Outer Diameter — 5.0 Millimeter FDA UDILength — 128 Millimeter FDA UDI
Category: Arthroscopic shaver system blade, single-use
SharkCut by Techcord co., Ltd — Class I — 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
- Formula — Stryker Corp. · Class I
- FMS — Medos International Sàrl · Class II
- DYONICS — Smith & Nephew, 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
- Techcord co., Ltd
Sources (1)
- FDA UDI b2320c50-7ca3-484e-ba27-671a5efe5573 36 fields · synced May 30, 2026