FDA.report

Tatum Surgical-Screw Driver Handle

Primary DI
00083208000232
Brand
Tatum Surgical-Screw Driver Handle
Company
Suncoast Dental, Inc
Model
Bone Fixation EZ-Screw Driver Handle
Catalog number
Bone Fixation EZ-Screw Driver Handle
Device description
Bone Fixation EZ-Screw Driver Handle for Bone Fixation Screws (Kit)
Published
2020-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00083208000232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208000232000832080002320832080002320083208000232

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-727-536-4880tatumcompliance@gmail.com

Regulatory Flags

DUNS number
078352849
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00083208135002DDP Dental MirrorDental MirrorDental Mirror2024-01-30
00083208136702DDP Extraction ForcepsForceps (67-A)Forceps (67-A)2024-01-30
00083208452215Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 2 (CB) AbutmentIP-PN-4.5 x 2 (CB)2021-06-04
00083208453212Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 3 (CB) AbutmentIP-PN-4.5 x 3 (CB)2021-06-04
00083208454219Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 4 (CB) AbutmentIP-PN-4.5 x 4 (CB)2021-06-04
00083208455216Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 5 (CB) AbutmentIP-PN-4.5 x 5 (CB)2021-06-04
00083208456213Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 6 (CB) AbutmentIP-PN-4.5 x 6 (CB)2021-06-04
00083208502217Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 2 (CB) AbutmentIP-PN-5.0 x 2 (CB)2021-06-04
00083208503214Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 3 (CB) AbutmentIP-PN-5.0 x 3 (CB)2021-06-04
00083208504211Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 4 (CB) AbutmentIP-PN-5.0 x 4 (CB)2021-06-04
00083208505218Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 5 (CB) AbutmentIP-PN-5.0 x 5 (CB)2021-06-04
00083208506215Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 6 (CB) AbutmentIP-PN-5.0 x 6 (CB)2021-06-04
00083208130526DDP Depth GaugeDepth GaugeDepth Gauge2022-10-19
00083208130427Zoll Scalpel Handle RoundScalpel Handle Round Z-4206 XLScalpel Handle Round2022-08-08
00083208131004DDP Extraction Forceps Forceps (1-A)Forceps (1-A)2022-06-30
00083208131509DDP Extraction Forceps Forceps (150-A)Forceps (150-A)2022-06-30

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