Identity
- Trade Name
- Malyugin Ring System 7.0mm FDA UDI
- Generic Name
- Intraocular retractor, single-use FDA UDI
- Model / Reference
- MAL-0002-1 FDA UDI
Identifiers
- Catalog Number
- MAL-0002-1 FDA UDI
- Primary DI / UDI-DI
- 00844685000043 FDA UDI
- FDA Product Code
- HOC FDA UDI
- GMDN Term
- Intraocular retractor, 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
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
No
FDA UDI
Category: Intraocular retractor, single-use
Malyugin Ring System 7.0mm by Microsurgical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraocular retractor, single-use.
- Disposable Iris Retract — Katena Products, Inc. · Class I
- Diamatrix Ltd — Diamatrix · Class I
- Fiber Optic Light Guide — ESCALON MEDICAL CORP · Class I
- APX 200 — APX OPHTHALMOLOGY LTD · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Iris Retractor. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microsurgical Technology, Inc.
Sources (1)
- FDA UDI 9a7142d5-dd39-4c3a-93e2-1d033991ad51 33 fields · synced May 30, 2026