FDA.reportPublic FDA data

Tap, Quick Connect, Reusable, Helical Ridge

Primary DI
M9702400030000
Brand
Tap, Quick Connect, Reusable, Helical Ridge
Company
Medshape, Inc.
Model
2400-03-000
Published
2023-04-06
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

Product Codes#

Code, Name table
CodeName
JECComponent, Traction, Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9702400030000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
601306413
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
false
Expiration date on label
true
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
M97015000009200Eclipse1500-00-09202017-02-16
M97029002402500DynaNail Mini2900-24-02502023-06-21
M97015000400000Eclipse1500-04-00002023-01-10
M97022001100010DynaNail2200-11-00012023-05-05
M97022002900000DynaNail2200-29-00002016-06-17
M97022010900400DynaNail2201-09-00402023-06-22
M9702300010500Eclipse2300-01-0502023-01-10
M9702300010550Eclipse2300-01-0552023-01-10
M9702300010600Eclipse2300-01-0602023-01-10
M9702300010700Eclipse2300-01-0702023-01-10
M9702300010800Eclipse2300-01-0802023-01-10
M9702300010900Eclipse2300-01-0902023-01-10
M97029000103000DynaNail Mini 2900-01-03002023-06-12
M97029000700000DynaNail Mini2900-07-00002019-04-09
M9703000010000DynaClip3000-01-0002018-11-26
M97030000400000DynaClip Forte3000-04-0002020-05-14
M9703000112220200DynaClip Quattro3000-11-2220202022-09-16
M9703000130000DynaClip Quattro3000-13-0002023-03-15
M9701000032250Morphix XT1000-03-2252017-05-19
M9701000032350Morphix XT1000-03-2352017-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277681231MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681248MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681255MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681262MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681279MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681286MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681293MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681309MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681316MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681323MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681330MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681347MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681354MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277680463MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680616MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681026MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681071MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681392MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
M97031000900010Tissue Protector, DynaFuseMedshape, Inc.JEC2024-04-01
M97031001200010Tube Caddy, DynaFuseMedshape, Inc.JEC2024-04-01
00861988000334DigiFix Sterile KitVIRAK ORTHOPEDICS LLCJEC2023-08-15
M97022000400330Protection Sleeve, 3.3mm, DynaNailMedshape, Inc.JEC2023-06-21
M97022000401400Protective Sleeve, 14mm, DynaNailMedshape, Inc.JEC2023-06-21
M97022000406330Parallel 3.3mm Protection Sleeve, DynaNail, DynaNailMedshape, Inc.JEC2023-06-21
M97029001000000Retention knob, Frame Assembly, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029001300000Tissue Protector, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029001500020Trial Sizer 110-140mm, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029001500030Trial Sizer 60-100mm, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029002200780Inner Sleeve, 7mm, Frame Assy, DynaNail MiniMedshape, Inc.JEC2023-06-14
M97029002300000Compression knob, Frame Assy DynaNail MiniMedshape, Inc.JEC2023-06-14