Identity
- Trade Name
- Centeze Centesis Catheter FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Centeze Centesis Catheter FDA UDI
- Model / Reference
- DRC-009-00 FDA UDI
- Description
- Centeze Centesis Catheter FDA UDI
Identifiers
- Catalog Number
- DRC-009-00 FDA UDI
- Primary DI / UDI-DI
- 00841268108684 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 5 French FDA UDI
Category: Closed-wound drain, non-bioabsorbable
Centeze Centesis Catheter by Galt Medical Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Galt Medical Corp.
Sources (2)
- FDA UDI abd95e5f-8649-4849-a3f5-4d546906317e 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026