DynaClip Bone Fixation System, Delta, 24mm x 16mm x 14mm x 12mm

GUDID M970300010241614120

Medshape, Inc.

Orthopaedic bone staple, non-adjustable
Primary Device IDM970300010241614120
NIH Device Record Key1c508bbf-6f72-4336-843d-1ff38324e83c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaClip Bone Fixation System, Delta, 24mm x 16mm x 14mm x 12mm
Version Model Number3000-10-24161412
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM970300010241614120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-07
Device Publish Date2022-09-16

Devices Manufactured by Medshape, Inc.

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00810028395893 - Half pin - 4 x 180mm with 25mm thread2024-07-17
00810028395930 - Half pin - 5 x 180mm with 25mm thread2024-07-17
00810028395978 - Half pin - 6 x 180mm with 35mm thread2024-07-17
00810028395992 - Half pin - 4 x 180mm with 45mm thread, stepped tip2024-07-17
00810028396005 - Half pin - 5 x 180mm with 50mm thread, stepped tip2024-07-17

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