AccessGUDID - DEVICE: Zip 24 Surgical Skin Closure Device (00853114007034)

GUDID

Device Identifier (DI) Information

Brand Name: Zip 24 Surgical Skin Closure Device
Version or Model: 667616001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7616
Company Name: ZIPLINE MEDICAL, INC.

Primary DI Number: 00853114007034
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 962534124 *Terms of Use

Device Description: Zip 24 Surgical Skin Closure Device, BSC

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):	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?
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.	Active	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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight and heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Centimeter

Device Record Status

Public Device Record Key: 6239613f-3a90-4940-a739-45b89f29a391
Public Version Date: February 01, 2021
Public Version Number: 5
DI Record Publish Date: March 16, 2017