DEVICE: Tatum Surgical-Osteotome Kit (00083208001116)

Device Identifier (DI) Information

Tatum Surgical-Osteotome Kit
Tatum Universal Straight Osteotome Kit
In Commercial Distribution
Osteotomez Str 24
Suncoast Dental, Inc
00083208001116
GS1

1
078352849 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
EMM Chisel, Osteotome, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

160f2c6c-57d7-48fc-9c45-9520b3f7846a
August 12, 2020
1
August 04, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
727-536-4880
tatumcompliance@gmail.com
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