AccessGUDID - DEVICE: Medichoice (10885632101717)

GUDID

Device Identifier (DI) Information

Brand Name: Medichoice
Version or Model: ORT02W
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632101717
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Towel Operating Room Pre-Washed De-Linted Cotton White 16 X 24 Inch Disposable 2 Pack Sterile Not Made With Natural Rubber Latex MediChoice

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?
14077	Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001858	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8485ae10-924c-4bc9-95f2-32882f37c13b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 20, 2016