AccessGUDID - DEVICE: NOVO Health Services, LLC (00812564039477)

GUDID

Device Identifier (DI) Information

Brand Name: NOVO Health Services, LLC
Version or Model: 123744
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 123744
Company Name: NOVO HEALTH SERVICES, LLC

Primary DI Number: 00812564039477
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: PLR GOWNS, MED 24 PK N/S

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?
35452	Isolation gown, reusable	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a reusable garment intended to be laundered after each use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYA	Gown, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080707	000

Device Exempt from Premarket Submission: No 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
Weight: 16.5 Pound
Width: 18 Inch
Height: 11 Inch

Device Record Status

Public Device Record Key: 6ef89974-dc7e-41c2-bdff-792f16eaacc8
Public Version Date: June 03, 2020
Public Version Number: 2
DI Record Publish Date: September 24, 2018