AccessGUDID - DEVICE: NOVO Health Services, LLC (00812564033789)

GUDID

Device Identifier (DI) Information

Brand Name: NOVO Health Services, LLC
Version or Model: 0125
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0125B
Company Name: NOVO HEALTH SERVICES, LLC

Primary DI Number: 00812564033789
Issuing Agency: GS1
Commercial Distribution End Date: June 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 069936106 *Terms of Use

Device Description: BULK TOWELS 25/NS (FF)

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:	No
Prescription Use (Rx):	Yes
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
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7cd006ed-e3a9-4563-baad-8f0dd43fa56a
Public Version Date: June 03, 2020
Public Version Number: 2
DI Record Publish Date: October 01, 2018