AccessGUDID - DEVICE: derma+flex QS (00854137001177)

GUDID

Device Identifier (DI) Information

Brand Name: derma+flex QS
Version or Model: QS70806
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QS70806
Company Name: Chemence Medical, Inc.

Primary DI Number: 00854137001177
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079163089 *Terms of Use

Device Description: Tissue Adhesive with Dauber/Nozzle AND derma+flex QS SourceMark, 0.7g product code M1201 and M1201-01

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 [?]
K101276	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: less than 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e24b952d-2102-4947-95c9-7faed11257ba
Public Version Date: August 15, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10854137001174	6	00854137001177	In Commercial Distribution	Box
20854137001171	6	10854137001174	In Commercial Distribution	Case
30854137001178	6	00854137001177	In Commercial Distribution	Box
40854137001175	10	30854137001178	In Commercial Distribution	Case