AccessGUDID - DEVICE: TatumSurgical/ITO HC 4.5 (CB)-Delrin HC for 4.5 One-Piece (CB) (00083208100451)

GUDID

Device Identifier (DI) Information

Brand Name: TatumSurgical/ITO HC 4.5 (CB)-Delrin HC for 4.5 One-Piece (CB)
Version or Model: Delrin Healing Cap for 4.5 One-Piece (CB)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ITO HC 4.5 (CB)
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208100451
Issuing Agency: GS1
Commercial Distribution End Date: May 29, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: ITO HC 4.5 (CB) - Delrin Healing Cap for 4.5 One-Piece (CB)

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:	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?
44881	Dental implant suprastructure kit	A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.5 Millimeter
Device Size Text, specify: 4.5 Delrin Healing Cap for 4.5 One-Piece (CB)

Device Record Status

Public Device Record Key: 11e5889f-9e82-46cc-befc-bbf344b9e4b8
Public Version Date: June 01, 2020
Public Version Number: 2
DI Record Publish Date: August 20, 2018