FDA.reportPublic FDA data

VersaTap/Lat Removal Tool

Primary DI
06009712642434
Brand
VersaTap/Lat Removal Tool
Company
ORTHO-DESIGN (PTY) LTD
Model
ADP003-1
Catalog number
ADP003-1
Device description
VersaTap/VersaLat Recovery - EasyOut, AO Coupling
Published
2023-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009712642434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009712642434060097126424346009712642434

GMDN Terms#

Term, Definition table
TermDefinition
Screw-extraction orthopaedic reamer, reusableA surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6612557406quality@trimedortho.com
+27128075172dianpeach@ortho-design.co.za

Regulatory Flags#

DUNS number
557386523
Device count
1
DM exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009712642236VersaPEEKAPP001APP0012025-08-11
06009712642243VersaPEEKAPP002APP0022025-08-11
06009712642267VersaPEEKAPP002-NAPP002-N2025-08-11
06009712642861VersaTap /VersaLat RecoveryADP003-2ADP003-22024-06-24
06009712642878VersaTap Tip RecoveryADP004-2ADP004-22024-06-24
06009712642885DoubleTapADP009-2ADP009-22024-06-24
06009712642892VersaPEEK Tapping ToolAPP001-2APP001-22024-06-24
06009712642731Anchor Threaded TitaniumATT-2x6 2S NDATT-2x6 2S ND2023-12-07
06009712642748Anchor Threaded TitaniumATT-3x11 2S NATT-3x11 2S N2023-12-07
06009712642755Anchor Threaded TitaniumATT-4x13 2S NATT-4x13 2S N2023-12-07
06009712642762Anchor Threaded TitaniumATT-6x17 2S NATT-6x17 2S N2023-12-07
06009712642779Anchor Impact PEEKABP-2.9x10 S NABP-2.9x10 S N2023-12-07
06009712642786Anchor Threaded PEEKATP-5.5x15 2S NATP-5.5x15 2S N2023-12-07
06009712642793Anchor Threaded Titanium-PEEKATX-6.5x17 2SATX-6.5x17 2S2023-12-07
06009712642809Anchor Threaded Titanium-PEEKATX-6.5x17 STATX-6.5x17 ST2023-12-07
06009712642816Anchor Threaded Titanium-PEEKATX-6.5x17 2TATX-6.5x17 2T2023-12-07
06009712642823Anchor Threaded Titanium-PEEKATX-6.5x17 2S NATX-6.5x17 2S N2023-12-07
06009712642656VersaTi 3mm DrillATP004-01ATP004-012023-10-05
06009712642403DueLock 2.9mm DrillADP013ADP0132023-09-07
06009712642441VersaTap Tip RemovalADP004-1ADP004-12023-09-07

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Primary DI, Brand, Company table
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B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
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