← Back to catalogue

LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal FDA UDI
Generic Name
24-hour urine specimen container IVD, no additive FDA UDI
Device Name
Sterile-EO FDA UDI
Model / Reference
4254 FDA UDI
Description
Sterile-EO FDA UDI

Identifiers

Primary DI / UDI-DI
00616784425436 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
24-hour 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

Yes

FDA UDI

Category: 24-hour urine specimen container IVD, no additive

LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as 24-hour urine specimen container IVD, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI bab2e6cd-7d80-41d9-8d3d-7c6de46765c9 33 fields · synced Jun 1, 2026