AccessGUDID - DEVICE: Lac-Mac (00627755571168)

GUDID

Device Identifier (DI) Information

Brand Name: Lac-Mac
Version or Model: 005DSBK-3XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 005DSBK-3XL
Company Name: Lac-Mac Limited

Primary DI Number: 00627755571168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201276334 *Terms of Use

Device Description: Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size 3XL

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):	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
OEA	Non-Surgical Gown

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 54 Inch

Device Record Status

Public Device Record Key: 136ab4d0-1a92-4a02-b027-74f4005e7466
Public Version Date: August 30, 2024
Public Version Number: 1
DI Record Publish Date: August 22, 2024