AccessGUDID - DEVICE: 3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit (00652221153586)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit
Version or Model: 504-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 504-101
Company Name: 3M COMPANY

Primary DI Number: 00652221153586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830016148 *Terms of Use

Device Description: Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and have clinically relevant sizes. The instruments in the kit need to be moist heat/steam sterilized before use.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	No
Prescription Use (Rx):	Yes
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?
46536	Orthodontic anchoring screw	A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Millimeter
Length: 8 Millimeter
Length: 6 Millimeter

Device Record Status

Public Device Record Key: 8e332b5a-0049-4dea-988d-184452f95a12
Public Version Date: January 03, 2024
Public Version Number: 3
DI Record Publish Date: October 23, 2015