AccessGUDID - DEVICE: Forsure (00897633001654)

GUDID

Device Identifier (DI) Information

Brand Name: Forsure
Version or Model: 16300024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16300024
Company Name: FORSURE MEDICAL PRODUCTS LLC

Primary DI Number: 00897633001654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033809722 *Terms of Use

Device Description: A non-sterile 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 is usually made of reinforced paper or non-woven materials. This is a single-use device.

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
Special Storage Condition, Specify: Store in Dry Conditions

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24" Blue

Device Record Status

Public Device Record Key: 579f932d-d19a-4e95-ac90-2c533e22620b
Public Version Date: December 22, 2021
Public Version Number: 3
DI Record Publish Date: January 23, 2018