AccessGUDID - DEVICE: LEVEL ONE ORTHOANCHOR (00888118006158)

GUDID

Device Identifier (DI) Information

Brand Name: LEVEL ONE ORTHOANCHOR
Version or Model: 01-350-08-09
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: KLS-Martin L.P.

Primary DI Number: 00888118006158
Issuing Agency: GS1
Commercial Distribution End Date: April 20, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 826499238 *Terms of Use

Device Description: SCREW, CROSSDRIVE, DRILL FREE, F/ RECTANGLE WIRE, 2.0 MM TISSUE COLLAR, TI-6AL-4V

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?
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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.5 X 8 MM THD, TTL=13 MM

Device Record Status

Public Device Record Key: 46d1fc28-e84a-4d16-849e-63e88a4f93db
Public Version Date: January 03, 2024
Public Version Number: 9
DI Record Publish Date: March 24, 2016