What is FDA product code PPQ?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.

Henry Schein · Transtibial Anterior Cruciate Ligament Kit → Orthopedic

Name: Henry Schein
Brand: Henry Schein

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code PPQ
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Henry Schein
Listed by	Henry Schein, Inc., United States
FDA product code	PPQ
Device type	Transtibial Anterior Cruciate Ligament Kit
Device class	Class 2
Regulation	21 CFR 888.3040
Premarket notification	Exempt
Record published	2023-08-27

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Henry Schein
Catalogue number	Size	Per pack	Status
5702179		4	In distribution

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.

Henry Schein

Who Else Makes It

Record

Specifications

Catalogue Numbers

Where China Actually Supplies