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

Andwin Scientific

Name: Andwin Scientific
Brand: Andwin Scientific

PAPKIT, 6000 XSF, 1 Super Frosted Slide, Scraper, Brush & 1oz Fixative Bottle

Registry build 21.09.26

1manufacturer

13catalogue 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 Andwin Scientific
Listed by	Andwin Scientific, United States
FDA product code	OHL
Device type	Pap Smear Kit
Device class	Class 2
Regulation	21 CFR 884.4530
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K890283
Record published	2017-08-02
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Case of 20, inner pack of 25, pack of 20, pack of 25, case of 100

Catalogue Numbers

Catalogue numbers for Andwin Scientific
Catalogue number	Size	Status
231048		In distribution
230180		In distribution
230152		In distribution
230110		In distribution
230100		In distribution
230160		In distribution
231057		In distribution
230080		In distribution
240080		In distribution
210070		In distribution
230170		In distribution
230040		In distribution
230075		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	3
Medical Action Industries	Medical Action Industries, Inc.	2
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.