AccessGUDID - DEVICE: Exact Medical Manufacturing, Inc. (00850015378522)

GUDID

Device Identifier (DI) Information

Brand Name: Exact Medical Manufacturing, Inc.
Version or Model: E104050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E104050
Company Name: EXACT MEDICAL MANUFACTURING, INC.

Primary DI Number: 00850015378522
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 014464314 *Terms of Use

Device Description: Surgical Gown, Large, AAMI 4 HaloGuard

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):	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?
35091	Surgical gown, single-use	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 single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYA	Gown, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 1a93e737-6654-4679-b71f-d1fb0ffaf3c9
Public Version Date: October 04, 2024
Public Version Number: 3
DI Record Publish Date: April 09, 2020