Identity
- Trade Name
- MARTIN LEWIS G.C. SYSTEM FDA UDI
- Generic Name
- Neiserria species agar culture medium IVD, basic FDA UDI
- Device Name
- MARTIN LEWIS G.C. SYSTEM FDA UDI
- Model / Reference
- V800 FDA UDI
- Description
- MARTIN LEWIS G.C. SYSTEM FDA UDI
Identifiers
- Catalog Number
- V800 FDA UDI
- Primary DI / UDI-DI
- M202V8001 FDA UDI
- 510(k) Number
- K950196 FDA UDI
- FDA Product Code
- JTY FDA UDI
- GMDN Term
- Neiserria species agar culture medium IVD, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 100 Millimeter FDA UDI
Category: Neiserria species agar culture medium IVD, basic
Martin Lewis G.c. System by Healthlink — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neiserria species agar culture medium IVD, basic.
- MARTIN LEWIS AGAR — Healthlink · Class II
- JEMBEC MARTIN LEWIS — Healthlink · Class II
- MARTIN LEWIS G.C. SYSTEM — Healthlink · Class II
Cleared under the same submission
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
- Healthlink
Sources (1)
- FDA UDI 20bf8bc4-0213-41ab-8629-19daa674929e 38 fields · synced May 31, 2026