AccessGUDID - DEVICE: AllCare (10182921000134)

GUDID

Device Identifier (DI) Information

Brand Name: AllCare
Version or Model: ORN-400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ORN-400
Company Name: ALLCARE, INC

Primary DI Number: 10182921000134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 400
Labeler D-U-N-S® Number*: 362187580 *Terms of Use

Device Description: OR Towel, Natural no dye, 100% Cotton, 16" x 25", pre-washed, non-sterile, 400/case

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):	Yes
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
FRL	Fiber, Medical, Absorbent

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: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2fdbe6d0-7572-48bf-810c-a93c47add3c9
Public Version Date: April 14, 2022
Public Version Number: 1
DI Record Publish Date: April 06, 2022