AccessGUDID - DEVICE: CARDINAL HEALTH (10885380109751)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: LQB003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LQB003
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380109751
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Butyl Topical Skin Adhesive, Dome Tip Clear, 0.5mL

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?
34164	Skin-approximation adhesive	A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPN	Tissue adhesive for the topical approximation of skin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122446	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94ba3dac-905e-46ab-b8a3-9e670a0d7a2f
Public Version Date: July 23, 2018
Public Version Number: 4
DI Record Publish Date: August 15, 2016