AccessGUDID - DEVICE: Tatum Surgical-Osteotome Kit (00083208001116)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Surgical-Osteotome Kit
Version or Model: Tatum Universal Straight Osteotome Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Osteotomez Str 24
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208001116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Tatum Universal Straight Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes: Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, "D" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0

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?
44886	Dental osteotome set	A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMM	Chisel, Osteotome, Surgical

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: 160f2c6c-57d7-48fc-9c45-9520b3f7846a
Public Version Date: August 12, 2020
Public Version Number: 1
DI Record Publish Date: August 04, 2020