AccessGUDID - DEVICE: maxill Safeguard Paper Sterilization Wrap

GUDID

Device Identifier (DI) Information

Brand Name: maxill Safeguard Paper Sterilization Wrap - 20" x 20" Crepe Paper
Version or Model: 60162
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAXILL, INC.

Primary DI Number: 00060705601629
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 079343581 *Terms of Use

Device Description: No description.

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):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device. See also: Instrument tray liner

FDA Product Code

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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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8dcfacff-a01d-40c2-99cc-5565ea118408
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 19, 2016