AccessGUDID - DEVICE: Tatum Integrity Implant Kit (00083208422225)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Integrity Implant Kit
Version or Model: Master Integrity Implant Kit 3.7-8.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASY ITI Kit Master
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208422225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Tatum Integrity Implant kit: A kit designed for simplicity and ease of use in placing Tatum Integrity Implants: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.5x11, 14, 17, 20, DR4.0x11, 14, 17, 20, DR4.5x11,14,17, 20, DR5.0x11, 14, 17, 20, DR6.0x11,14,17,20. DR7.0x11, 14,17. DR8.0x11, 14, 17. HT.02, 03, 03L, 06, 06L, 07, 07L, 08, 09, 09L, 26, 27, 29, & 30. Tatum Ratchet, set of 4 paralleling pins. Autoclaveable Cassette/Container for all pieces

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:	Yes
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?
55847	Dental implant system	A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e70a79bc-f49f-4524-8daf-db0d29f74503
Public Version Date: August 10, 2020
Public Version Number: 1
DI Record Publish Date: July 31, 2020