FDA.reportPublic FDA data

Trial Sizer 60-100mm, DynaNail Mini

Primary DI
M97029001500030
Brand
Trial Sizer 60-100mm, DynaNail Mini
Company
Medshape, Inc.
Model
2900-15-0003
Published
2023-06-14
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M97029001500030PrimaryHIBCC0

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
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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