What is FDA product code PYB?

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 › SurgicalMinor Surgical Procedures Tray

PAL™

Name: PAL™
Brand: PAL™

Catalogue number 00884450055144, listed by Merit Medical Systems, Inc., United States, under Minor Surgical Procedures Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Hubei.

Chinese manufacturers registered for FDA product code PYB
Manufacturer	City	Province	Registered as	Device types
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33

Record

Regulatory record for PAL™
Listed by	Merit Medical Systems, Inc., United States
FDA product code	PYB
Device type	Minor Surgical Procedures Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2018-09-17
Record revised	2020-10-21 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Pack of 4, pack of 25

Catalogue Numbers

Catalogue numbers for PAL™
Catalogue number	Size	Status
00884450055144		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Merit Medical®	Merit Medical Systems, Inc.	290
Instrapac	Robinson Healthcare Limited	65
Arbutus Medical	Arbutus Medical, Inc	11
Punch Biopsy Set	Blink Medical Ltd	2
Biopsy Set	Blink Medical Ltd	2
Minor Ops Set	Blink Medical Ltd	2
Full Biopsy Set	Blink Medical Ltd	2
Atec	Hologic, Inc.	2
Henry Schein	Henry Schein, Inc.	2
Mammosite	Hologic, Inc.	2
Full Minor Op’s Set	Blink Medical Ltd	1
MoHs Set	Blink Medical Ltd	1

Showing 12 of 18. All products under Minor Surgical Procedures Tray

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.