AccessGUDID - DEVICE: Incise Film (00813465012194)

GUDID

Device Identifier (DI) Information

Brand Name: Incise Film
Version or Model: 9701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9701
Company Name: HURRICANE MEDICAL INC

Primary DI Number: 00813465012194
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 093377724 *Terms of Use

Device Description: Cover lashes, lids, and brow for ophthalmic surgery, or office procedures. Adhesive area 12.7 x 18.4 cm.

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):	Yes
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?
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 22.8 Centimeter
Width: 12.7 Centimeter

Device Record Status

Public Device Record Key: 79b1c7d8-174c-4a1a-8218-6868ad637208
Public Version Date: May 13, 2020
Public Version Number: 1
DI Record Publish Date: May 05, 2020