MakEdge 1418260
by Makvin Surgical LLC GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850072675060 | Date16 Dec 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- MakEdge
- Generic Name
- Ophthalmic knife, single-use
- Model / Ref / Catalog
- 1418260
- Primary DI / UDI-DI
- 00850072675060
- FDA Product Code
- HNN
- GMDN Term
- Ophthalmic knife, single-use
- Device Class
- Class I
- Regulation Number
- 886.4350
- Commercial Distribution
- In Commercial Distribution
Other devices from Makvin Surgical LLC
Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No