What is FDA product code OHL?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Obstetrics & Gynecology › SurgicalPap Smear Kit

Medical Action Industries

Name: Medical Action Industries
Brand: Medical Action Industries

2 catalogue numbers from 76766, listed by Medical Action Industries, Inc., United States, under Pap Smear Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Hubei.

Chinese manufacturers registered for FDA product code OHL
Manufacturer	City	Province	Registered as	Device types
Wuhan Landing Intelligence Medical Co., Ltd.	Wuhan	Hubei	Manufacturer	17

Record

Regulatory record for Medical Action Industries
Listed by	Medical Action Industries, Inc., United States
FDA product code	OHL
Device type	Pap Smear Kit
Device class	Class 2
Regulation	21 CFR 884.4530
Premarket notification	Exempt
Record published	2017-08-11
Record revised	2020-07-15 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Special storage condition: STORE AT ROOM TEMPERATURE
Packaging	Pack of 20
Distribution end date	2020-07-13
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medical Action Industries
Catalogue number	Size	Status
76766		Withdrawn
76549		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Andwin Scientific	Andwin Scientific	13
Cardinal Health	Cardinal Health 200, LLC	3
Aero-Med	Aero-MED LLC	2

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.