AccessGUDID - DEVICE: TUTEM (00817583020390)

GUDID

Device Identifier (DI) Information

Brand Name: TUTEM
Version or Model: 6055-5 COLD COUTURE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6055-5 COLD COUTURE
Company Name: Alpha Pro Tech, Inc.

Primary DI Number: 00817583020390
Issuing Agency: GS1
Commercial Distribution End Date: April 19, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 102710720 *Terms of Use

Device Description: EARLOOP, TUTEM-COLD COUTURE.

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:	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?
43315	Surgical hood	A non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, 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: 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: 81f4340b-a7e7-4543-9f07-6462e0ed2efc
Public Version Date: June 12, 2025
Public Version Number: 8
DI Record Publish Date: November 03, 2016