AccessGUDID - DEVICE: Ink Align (00843696195069)

GUDID

Device Identifier (DI) Information

Brand Name: Ink Align
Version or Model: RT-4426-OUVN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flow X Ray Corporation

Primary DI Number: 00843696195069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 010016319 *Terms of Use

Device Description: Qfix Ink Align, UV Pink, Box of 25 Applicators. Includes 21 gauge surgical grade, sterile hypodermic needles.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
61783	Tattoo ink, dermal	A sterile, synthetic, implantable dye solution intended to be injected between the layers of the skin, using a tattoo needle and hand-held ink injector, for aesthetic pigmentation of the skin and visible mucous membranes. It is typically pH balanced for dermal applications and does not contain animal-derived materials. It may be implanted for a variety of reasons (e.g., for cosmetic decoration, to replace colour in the skin for patients affected by pigment deficiencies, for radiotherapy marking).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	Marker, Skin

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82dac669-c138-4977-baec-e13d3879c49d
Public Version Date: June 28, 2023
Public Version Number: 2
DI Record Publish Date: June 01, 2021