AccessGUDID - DEVICE: LOWLAND (D8070362254T1)

GUDID

Device Identifier (DI) Information

Brand Name: LOWLAND
Version or Model: 03-622-54T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03-622-54T
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D8070362254T1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 15, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: LOWLAND NITI NAT 16X22 LW PK10

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?
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZC	WIRE, ORTHODONTIC

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 350b3917-8909-4758-8f6f-4b877b7f2d80
Public Version Date: January 15, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2020