AccessGUDID - DEVICE: ProMax Surgical Gown (00634916795493)

GUDID

Device Identifier (DI) Information

Brand Name: ProMax Surgical Gown
Version or Model: 75614905
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916795493
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Double-needle Flat Felled Chainstitch Construction

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):	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?
11902	Surgical gown, reusable	A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. 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 [?]
K041540	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 35ec9a3b-d81c-4c8a-8353-560677c788d6
Public Version Date: October 18, 2023
Public Version Number: 1
DI Record Publish Date: October 10, 2023