AccessGUDID - DEVICE: Tatum Sinus Instrument (00083208197000)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Sinus Instrument
Version or Model: Tatum Sinus #7 - Double ended
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Sinus #7
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208197000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Tatum double ended sinus Instrument #7, (Red)

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?
64314	Dental elevator, sinus lift	A hand-held, manual, dental surgical instrument specially designed to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. It is typically a metal instrument with single- or double-ended blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMJ	Elevator, Surgical, Dental

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: 31a218ce-efa2-4a2d-a35d-4c412b738c03
Public Version Date: December 04, 2020
Public Version Number: 2
DI Record Publish Date: April 10, 2020