What is FDA product code PYG?

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.

General & Plastic Surgery › SurgicalSuction Catheter Kit

McKesson

Name: McKesson
Brand: McKesson

Suction Catheter Kit Rigid Tray 1 Pair of Gloves 10FR (50/cs)

Registry build 21.09.26

1manufacturer

14catalogue numbers in this listing

Who Else Makes It

Registered in Henan.

Chinese manufacturers registered for FDA product code PYG
Manufacturer	City	Province	Registered as	Device types
Henan Yadu Industrial Co., Ltd.	Changyuan	Henan	Contract manufacturer	35

Record

Regulatory record for McKesson
Listed by	Mckesson Medical-Surgical Inc.
FDA product code	PYG
Device type	Suction Catheter Kit
Device class	Class 1
Regulation	21 CFR 878.4200
Premarket notification	Exempt
Record published	2024-09-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Case of 50

Catalogue Numbers

Catalogue numbers for McKesson
Catalogue number	Size	Status
16-DT6FRKR		In distribution
16-DT8FRKR		In distribution
16-DT10FRKR		In distribution
16-DT6FRK		In distribution
16-DT10FRK		In distribution
16-DT14FRK		In distribution
16-DT8FRK		In distribution
16-DT16FRK		In distribution
16-DT18FRKR		In distribution
16-DT12FRK		In distribution
16-DT16FRKR		In distribution
16-DT12FRKR		In distribution
16-DT18FRK		In distribution
16-DT14FRKR		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Curaplex	Bound Tree Medical, LLC	1

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.