Identity
- Trade Name
- Centurion FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Device Name
- CVC INSERTION TRAY FDA UDI
- Model / Reference
- HT405 FDA UDI
- Description
- CVC INSERTION TRAY FDA UDI
Identifiers
- Catalog Number
- HT405 FDA UDI
- Primary DI / UDI-DI
- 10653160375999 FDA UDI
- 510(k) Number
- K213481 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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: General surgical procedure kit, medicated
Centurion by Centurion Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General surgical procedure kit, medicated.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Cleared under the same submission
K213481 also covers:
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
- Centurion — Centurion Medical Products
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Centurion Medical Products
Sources (1)
- FDA UDI 12e08a0e-6519-452e-8c8b-3353bbb56816 36 fields · synced May 30, 2026