Identity
- Trade Name
- GOBEN FDA UDI
- Generic Name
- Polymeric urethral stent, short-term FDA UDI
- Device Name
- Closed Wound Drainage System, Silicone Drainage Kit 100ml Bulb Reservoir, Flat Drain 10mm, with Perforation, Sterile FDA UDI
- Model / Reference
- JD14-R490107 FDA UDI
- Description
- Closed Wound Drainage System, Silicone Drainage Kit 100ml Bulb Reservoir, Flat Drain 10mm, with Perforation, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06979032640031 FDA UDI
- FDA Product Code
- GBA FDA UDI
- GMDN Term
- Polymeric urethral stent, short-term 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polymeric urethral stent, short-term
Goben by Huzhou Junda Industry Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric urethral stent, short-term.
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- Firlit-Kluge — COOK INCORPORATED · Class II
- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
- Surveyor Urethral Measurement Device — SRS Medical Systems, Inc. · Class III
- Koyle — COOK INCORPORATED · Class II
- The Spanner Temporary Prostatic Stent — SRS Medical Systems, Inc. · Class III
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 |
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Manufacturer
- Manufacturer
- Huzhou Junda Industry Co., Ltd.
Sources (1)
- FDA UDI 07244636-3add-49fb-bfc4-6dd6ea331345 33 fields · synced May 30, 2026