Identity
- Trade Name
- Bartels FDA UDI
- Generic Name
- Culture medium antimicrobial supplement IVD FDA UDI
- Device Name
- Cul-Trol FDA UDI
- Model / Reference
- B1029-41 FDA UDI
- Description
- Cul-Trol FDA UDI
Identifiers
- Catalog Number
- B1029-41 FDA UDI
- Primary DI / UDI-DI
- 05391516747318 FDA UDI
- 510(k) Number
- K834115 FDA UDI
- FDA Product Code
- JSK FDA UDI
- GMDN Term
- Culture medium antimicrobial supplement IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Culture medium antimicrobial supplement IVD
Bartels by Clark Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Culture medium antimicrobial supplement IVD.
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- H.PYLORI SELECTIVE SUPP.(DENT) — OXOID LIMITED · Class I
Cleared under the same submission
K834115 also covers:
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
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI 07885592-1dd8-4a14-a40b-04a1e1d3afc4 38 fields · synced Jun 8, 2026