AccessGUDID - DEVICE: LiquiBand Flex (05036912000697)

GUDID

Device Identifier (DI) Information

Brand Name: LiquiBand Flex
Version or Model: LBF001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED

Primary DI Number: 05036912000697
Issuing Agency: GS1
Commercial Distribution End Date: December 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 236059171 *Terms of Use

Device Description: No description.

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?
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 [?]
K102076	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5870abb4-b33d-4b17-b267-5b9c509c4eb1
Public Version Date: December 28, 2018
Public Version Number: 5
DI Record Publish Date: September 06, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05036912000925	6	05036912000529	2018-12-28	Not in Commercial Distribution	Shipper Carton
05036912000529	10	05036912000697	2018-12-28	Not in Commercial Distribution	Carton