AccessGUDID - DEVICE: Arjo Wiggins Medical, Inc. (00815588023750)

GUDID

Device Identifier (DI) Information

Brand Name: Arjo Wiggins Medical, Inc.
Version or Model: 101077P1818
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 101077P1818
Company Name: STERIMED INC.

Primary DI Number: 00815588023750
Issuing Agency: GS1
Commercial Distribution End Date: October 23, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 182052670 *Terms of Use

Device Description: 77P 18X18,500_CASE U

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 [?]
K931202	000

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
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68556626-5f1d-42bf-8862-4d7339759ff2
Public Version Date: January 04, 2021
Public Version Number: 5
DI Record Publish Date: September 21, 2016