What is FDA product code PUA?

This product code is the class II exempt counterpart of HDC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › SurgicalTenaculum, Uterine, Exempt

BR Surgical, LLC

Name: BR Surgical, LLC
Brand: BR Surgical, LLC

SCHROEDER-BRAUN Tenaculum Forceps, straight, single-use, 9 3/4", 10 per box

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PUA
Manufacturer	City	Province	Registered as	Device types
Zhejiang Shuyou Surgical Instrument Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	13

Record

Regulatory record for BR Surgical, LLC
Listed by	BR Surgical LLC, United States
FDA product code	PUA
Device type	Tenaculum, Uterine, Exempt
Device class	Class 2
Regulation	21 CFR 884.4530
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2024-07-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for BR Surgical, LLC
Catalogue number	Size	Status
BR98-50425-EACH		In distribution
BR98-50425		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hayden Medical	Hayden Medical Inc	34
Instrapac	Robinson Healthcare Limited	4

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.