AccessGUDID - DEVICE: SURGIPLUS (74895237141535)

GUDID

Device Identifier (DI) Information

Brand Name: SURGIPLUS
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 68-6149-B
Company Name: KENPAX INTERNATIONAL LIMITED

Primary DI Number: 74895237141535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 686206765 *Terms of Use

Device Description: Warm-up Jacket, Blue, XL A non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

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?
58382	Scrub suit, single-use	A two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	Accessory, Surgical Apparel

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: 047730d2-b8bd-40b2-b896-57dbc6e26496
Public Version Date: April 07, 2021
Public Version Number: 2
DI Record Publish Date: March 15, 2021