Identity
- Trade Name
- Medegen Medical Products, LLC FDA UDI
- Generic Name
- Non-evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- 4oz STL CTR Screwcap BG 100/cs 60 cs/ski FDA UDI
- Model / Reference
- M4928 FDA UDI
- Description
- 4oz STL CTR Screwcap BG 100/cs 60 cs/ski FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00700812002079 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Non-evacuated urine specimen container IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-evacuated urine specimen container IVD, no additive
Medegen Medical Products, LLC by Medegen Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medegen Medical Products
Sources (1)
- FDA UDI bd5fbd3d-2e64-4e84-bef9-f97e84590a8a 33 fields · synced May 30, 2026