AccessGUDID - DEVICE: Sterilization Wrap, Reliance Solo S200 (00841982101480)

GUDID

Device Identifier (DI) Information

Brand Name: Sterilization Wrap, Reliance Solo S200
Version or Model: WLJ1Z1086B24
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AHLSTROM NONWOVENS LLC

Primary DI Number: 00841982101480
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 240
Labeler D-U-N-S® Number*: 039993345 *Terms of Use

Device Description: WLJ1Z1086B, Sterilization Wrap, Reliance Solo 200, 24 x 24 inches [] 480 sheets/case, 2 bonded sheets per application = 240 applications/case. Wrap with Green layer on outside. Review IFU.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ab564c1-2f96-4a96-ad59-aa2a802e7a3f
Public Version Date: October 21, 2021
Public Version Number: 1
DI Record Publish Date: October 13, 2021