AccessGUDID - DEVICE: TatumSurgical/Small Ball Housing (00083208200014)

GUDID

Device Identifier (DI) Information

Brand Name: TatumSurgical/Small Ball Housing
Version or Model: Small Ball Housing
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HBP-S
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208200014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Small Ball Housing

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?
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	Attachment, Precision, All

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: Small Ball Housing for 2mm Ball

Device Record Status

Public Device Record Key: a9f8ebde-6107-4c8a-b6ca-a4e844d3c734
Public Version Date: January 19, 2023
Public Version Number: 4
DI Record Publish Date: July 18, 2018