AccessGUDID - DEVICE: Opti-Tatt™ Crosshairs (00714646001009)

GUDID

Device Identifier (DI) Information

Brand Name: Opti-Tatt™ Crosshairs
Version or Model: UTRT-4200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UTRT-4200
Company Name: Bionix, LLC

Primary DI Number: 00714646001009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 117844489 *Terms of Use

Device Description: Opti-Tatt, Crosshair, Sheet of 24

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?
62057	Skin marking transfer paper	A non-sterile, noninvasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure, such as accurate subcutaneous injection spacing. It is a non-latex transfer paper designed to be applied to the skin and then peeled away to leave the ink dots, which are subsequently removed from the skin (e.g., with alcohol) after the procedure. This is a single-use device.	Active	false

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Fahrenheit
Special Storage Condition, Specify: To maximize shelf-life, keep Opti-Tatt in the freezer between use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55e44289-a9a5-41f8-a286-57701b2331a3
Public Version Date: September 26, 2024
Public Version Number: 4
DI Record Publish Date: June 12, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10714646001006 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)551-7096
Email: Bionix@bionix.com

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