AccessGUDID - DEVICE: Tatum Surgical/Hand Tool (00083208260049)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Surgical/Hand Tool
Version or Model: Hand Tool / HT.26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HT.26
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208260049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Hand Tool #26 Adapter for standard 4mm square drive ratchet to fit Tatum drivers

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?
64373	Dental torque wrench adaptor	A component of a dental torque wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a specific endpiece(s). It is intended to be used during an invasive surgical procedure and is dedicated to dental use only. This is a reusable device.	Active	false

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: 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: Hand Tool #26 Adapter for standard 4mm square drive ratchet to fit Tatum drivers

Device Record Status

Public Device Record Key: c1d306b8-27d3-4e93-9df5-1f7c87b7b84b
Public Version Date: December 07, 2020
Public Version Number: 2
DI Record Publish Date: April 15, 2018