AccessGUDID - DEVICE: Coulmed (10810087350250)

GUDID

Device Identifier (DI) Information

Brand Name: Coulmed
Version or Model: DI-5934-706
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DI-5934-706
Company Name: Coulmed Products Group LLC

Primary DI Number: 10810087350250
Issuing Agency: GS1
Commercial Distribution End Date: January 06, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 047115479 *Terms of Use

Device Description: Round SMS Bouffant Cap 27"

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?
32297	Surgical cap, single-use	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYF	CAP, SURGICAL

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: e338ef51-155c-4292-a924-a1b9aa857521
Public Version Date: July 17, 2024
Public Version Number: 2
DI Record Publish Date: January 06, 2023