Identity
- Trade Name
- EDGETEC FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- 20 Gauge Vitrectomy Knife, Straight FDA UDI
- Model / Reference
- EDGE8-20GS FDA UDI
- Description
- 20 Gauge Vitrectomy Knife, Straight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840120303120 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
No
FDA UDI
Category: Scalpel, single-use
Edgetec by Unique Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · 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
- Unique Technologies, Inc.
Sources (1)
- FDA UDI 9b5a53e1-9439-4b8b-9589-ad6b89252832 34 fields · synced May 31, 2026