Identity
- Trade Name
- JEDMED FDA UDI
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, single-use FDA UDI
- Device Name
- FORCEPS BAYONET CUSHING 19.5CM FDA UDI
- Model / Reference
- 54-0500 FDA UDI
- Description
- FORCEPS BAYONET CUSHING 19.5CM FDA UDI
Identifiers
- Catalog Number
- 54-0500 FDA UDI
- Primary DI / UDI-DI
- M6335405000 FDA UDI
- FDA Product Code
- GEN FDA UDI
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
Jedmed by JEDMED Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
- GoldCath — DEMERSAN BIYOTEKNOLOJI İMALAT SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
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
- JEDMED Instrument Company
Sources (1)
- FDA UDI 47edbac3-b6c6-4ddd-b31c-9a94fac208cf 34 fields · synced May 30, 2026