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Medegen Medical Products, LLC

FDA UDI

Class I (US FDA UDI)

by Medegen Medical Products

Identity

Trade Name
Medegen Medical Products, LLC FDA UDI
Generic Name
Sterile urine specimen container IVD FDA UDI
Device Name
Spec Cont Wide Mouth 3oz 400/cs 20 cs/sk FDA UDI
Model / Reference
M4937 FDA UDI
Description
Spec Cont Wide Mouth 3oz 400/cs 20 cs/sk FDA UDI

Identifiers

Primary DI / UDI-DI
00700812002086 FDA UDI
FDA Product Code
NNI FDA UDI
GMDN Term
Sterile urine specimen container IVD 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: Sterile urine specimen container IVD

Medegen Medical Products, LLC by Medegen Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterile urine specimen container IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medegen Medical Products

Sources (1)

  • FDA UDI d1b1f474-c0ac-49d7-a2cb-a90e17462de2 33 fields · synced Jun 8, 2026