AccessGUDID - DEVICE: Batrik SaveFace Disposable Shoe Covers, Bulk (00690521017054)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik SaveFace Disposable Shoe Covers, Bulk
Version or Model: SF-SC02UV-8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SF-SC02UV-8
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521017054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: SaveFace Shoe Covers, anti skid, universal size, Blue

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":	Yes
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?
13575	Shoe cover, conductive, non-sterile	A non-sterile device made of conductive material designed to reduce the risk of static electricity build-up and intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FXP	Cover, Shoe, Operating-Room

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Store at ambient temperature & normal humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2a59dfe-09f0-4e85-bf3e-efb088489d36
Public Version Date: December 31, 2020
Public Version Number: 1
DI Record Publish Date: December 23, 2020