Identity
- Trade Name
- MEDPOR FDA UDI
- Generic Name
- Closed-wound drainage kit FDA UDI
- Device Name
- 10 French Drain System, Sterile FDA UDI
- Model / Reference
- 6648 FDA UDI
- Description
- 10 French Drain System, Sterile FDA UDI
Identifiers
- Catalog Number
- 6648 FDA UDI
- Primary DI / UDI-DI
- 37613252088463 FDA UDI
- 510(k) Number
- K833586 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound drainage kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Closed-wound drainage kit
Medpor by Stryker Leibinger — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drainage kit.
- Closed Wound Suction — C. R. Bard, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Closed Wound Suction — C. R. Bard, Inc. · Class I
- BAROVAC® Evacuator Closed Wound Drainage System(SS) — Sewoon Medical Co., Ltd. · Class I
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- SKATER™ Single Step Drainage Set — Argon Medical Devices, Inc. · Class I
Cleared under the same submission
K833586 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
- Stryker Leibinger
Sources (1)
- FDA UDI 7b8c5392-9746-4550-9ddb-063df154be61 35 fields · synced Jun 1, 2026