AccessGUDID - DEVICE: Copioumed (04719882250477)

GUDID

Device Identifier (DI) Information

Brand Name: Copioumed
Version or Model: SCN0B201-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COPIOUMED INTERNATIONAL INC.

Primary DI Number: 04719882250477
Issuing Agency: GS1
Commercial Distribution End Date: September 23, 2024
Device Count: 100
Labeler D-U-N-S® Number*: 658318113 *Terms of Use

Device Description: Copioumed Surgical Cap with Ties offers a comfortable and enhanced fit for wearers, as it is equipped with ties on the back for an adjustable size. The wide-forehead surgical cap’s design also ensures a close fit, especially for people with long hair. In addition, the wide and flat forehead contains no elastic, so this surgical cap won’t leave a mark. Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.

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):	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: 61ef8970-243d-42e0-bc91-d30f8f3244c1
Public Version Date: November 14, 2024
Public Version Number: 2
DI Record Publish Date: August 31, 2022