AccessGUDID - DEVICE: ORTH ARCH (D909800062W1)

GUDID

Device Identifier (DI) Information

Brand Name: ORTH ARCH
Version or Model: DBL ENDED LIGATURE DIRECTOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-062W
Company Name: Ortho Arch Company Inc

Primary DI Number: D909800062W1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020956330 *Terms of Use

Device Description: LITE 3/8' DBL ENDED LIGATURE DIRECTOR

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:	No
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?
37413	Orthodontic ligature director	A hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65a5c69f-ea1b-4125-b722-b0a70ac97c3f
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 24, 2022