FDA.reportPublic FDA data

Tatum Surgical-Screw Driver

Primary DI
00083208000256
Brand
Tatum Surgical-Screw Driver
Company
Suncoast Dental, Inc
Model
Bone Fixation Screw Latch-Grip Driver
Catalog number
Bone Fixation Screw Latch-Grip Driver
Device description
Bone Fixation Screw Latch-Grip Driver for the EZ bone fixation screw kit
Published
2020-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208000256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208000256000832080002560832080002560083208000256

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-727-536-4880tatumimplants@verizon.net

Regulatory Flags#

DUNS number
078352849
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00083208102202Tatum Surgical-AnalogAnalog ITI 5.0 DIMAnalog ITI 5.0 DIM2026-02-12
00083208003332Universal Screw Removal KitUniversal Screw Removal KitUniversal Screw Removal Kit2025-09-29
00083208163333Tatum EZ-Flex Periotome KitTatum EZ-Flex Periotome KitTatum EZ-Flex Periotome Kit2025-09-29
00083208130519Scalpel RemoverScalpel Remover T/CScalpel Remover T/C2021-08-06
00083208191121Tatum Sinus Instrument Kit Tatum Sinus KitTatum Sinus Kit2024-09-25
00083208130274RulerRulerRuler2021-02-03
00083208162220Tatum EZ Out Periotome E KitTatum EZ Out Periotome E KitTatum EZ Out Periotome E Kit2024-07-30
00083208130052Tatum Offset Seating toolSeating ToolSeating tool O/S2020-04-20
00083208130403Tatum Straight Seating toolSeating ToolSeating tool Straight2020-04-20
00083208000003Tatum Surgical Bone Fixation Screw KitE-Z bone Fixation Screw KitEZ-Bone Fixation Screw Kit2020-11-13
00083208006135Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x3mmBone Fix Scw 1.5x3mm2019-12-24
00083208006142Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x4mmBone Fix Scw 1.5x4mm2019-12-24
00083208006173Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x8mmBone Fix Scw 1.75x8mm2019-12-24
00083208006180Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x10mmBone Fix Scw 1.75x10mm2019-12-24
00083208006197Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x12mmBone Fix Scw 1.75x12mm2019-12-24
00083208006203Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.75x14mmBone Fix Scw 1.75x14mm2019-12-24
00083208006210Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x15mmBone Fix Scw 1.5x15mm2019-12-24
00083208006227Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x18mmBone Fix Scw 1.5x18mm2019-12-24
00083208006234Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x21mmBone Fix Scw 1.5x21mm2019-12-24
00083208006241Tatum Surgical Bone Fixation ScrewBone Fix Scw 1.5x24mmBone Fix Scw 1.5x24mm2019-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031778086NAInstitut Straumann AGNDP2026-06-03
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