FDA.report

DoubleTap

Primary DI
06009712642885
Brand
DoubleTap
Company
ORTHO-DESIGN (PTY) LTD
Model
ADP009-2
Catalog number
ADP009-2
Device description
DoubleTap, Anchor Tapping Tool, 6mm, AO Coupling
Published
2024-06-24
Public version status
New
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

Contact Domains

Product Codes

CodeName
HWXTap, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06009712642885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06009712642885060097126428856009712642885

GMDN Terms

TermDefinition
Orthopaedic bone screw starter/notcherA hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter6Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+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

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06009712642755Anchor Threaded TitaniumATT-4x13 2S NATT-4x13 2S N2023-12-07
06009712642762Anchor Threaded TitaniumATT-6x17 2S NATT-6x17 2S N2023-12-07
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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
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