AccessGUDID - DEVICE: NOVO Health Services, LLC (00812564038739)

GUDID

Device Identifier (DI) Information

Brand Name: NOVO Health Services, LLC
Version or Model: 6737
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6737C
Company Name: NOVO HEALTH SERVICES, LLC

Primary DI Number: 00812564038739
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 069936106 *Terms of Use

Device Description: THYROID SHEET

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?
44041	Vagus nerve electrical stimulation system lead	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080796	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 3.0 Pound
Width: 8 Inch
Height: 4 Inch

Device Record Status

Public Device Record Key: d403a39a-3f74-487d-81cf-4cb5fe173422
Public Version Date: June 02, 2020
Public Version Number: 2
DI Record Publish Date: September 24, 2018