What is FDA product code PWL?

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.

Dental › SurgicalOral Surgery Tray

Stradis Medical, LLC.

Name: Stradis Medical, LLC.
Brand: Stradis Medical, LLC.

Catalogue number 400900YGS, listed by Stradis Healthcare, United States, under Oral Surgery Tray. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (2), Hubei (1).

Chinese manufacturers registered for FDA product code PWL
Manufacturer	City	Province	Registered as	Device types
Shanghai Jolly Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	99
Shanghai Lions Industrial Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	82
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33

Record

Regulatory record for Stradis Medical, LLC.
Listed by	Stradis Healthcare, United States
FDA product code	PWL
Device type	Oral Surgery Tray
Device class	Class 1
Regulation	21 CFR 872.4565
Premarket notification	Exempt
Record published	2022-04-13
Record revised	2023-01-26 (version 3)

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
Label carries	lot or batch number, expiry date
Packaging	Case of 6
Distribution end date	2023-01-25

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC.
Catalogue number	Size	Status
400900YGS		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stradis Healthcare	Stradis Healthcare	215
Stradis	Stradis Healthcare	147
Invenio	GRI-Alleset, Inc.	58
Cardinal Health	Cardinal Health 200, LLC	16
Henry Schein	Henry Schein, Inc.	5
Patient Pack NSU V2	Stradis Healthcare	1
Hiossen Simple Instrument KIT	Osstem Implant Co., Ltd.	1
Hiossen Basic Instrument KIT	Osstem Implant Co., Ltd.	1
Surgical Room	Stradis Healthcare	1
Instrapac	Robinson Healthcare Limited	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.