Identity
- Trade Name
- Marketlab, Inc FDA UDI
- Generic Name
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
- Device Name
- Nylon Small Biopsy Bags - 2"W x 1.125"H - 200/pk FDA UDI
- Model / Reference
- 10980 FDA UDI
- Description
- Nylon Small Biopsy Bags - 2"W x 1.125"H - 200/pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817517025101 FDA UDI
- FDA Product Code
- KET FDA UDI
- GMDN Term
- Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Marketlab, Inc by Marketlab Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Marketlab Inc.
Sources (1)
- FDA UDI 9a090f8d-a072-41a5-9035-da750e5970df 34 fields · synced Jun 8, 2026