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Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
REMEL FDA UDI
Generic Name
Culture medium control FDA UDI
Device Name
Phenol Red Broth w/1% Maltose 20/PK FDA UDI
Model / Reference
R062332 FDA UDI
Description
Phenol Red Broth w/1% Maltose 20/PK FDA UDI

Identifiers

Catalog Number
R062332 FDA UDI
Primary DI / UDI-DI
00848838008870 FDA UDI
FDA Product Code
JSF FDA UDI
GMDN Term
Culture medium control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2320 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Culture medium control

A medical device directory, showcasing a comprehensive 2-3 paragraph overview of the REMEL device. This device consists of paper discs impregnated with freeze-dried microorganisms, used to determine if a culture medium is suitable for growth.

Similar devices

Also classified as Culture medium control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI f9580cb0-937f-458a-adf7-dd181087d0a3 34 fields · synced Jul 11, 2026