DynaClip Bone Fixation System, Delta, 28mm x 16mm x 14mm x 12mm

GUDID M970300010281614120

Medshape, Inc.

Orthopaedic bone staple, non-adjustable
Primary Device IDM970300010281614120
NIH Device Record Key72944d92-b8b7-40ee-a75a-76783b9f6e9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaClip Bone Fixation System, Delta, 28mm x 16mm x 14mm x 12mm
Version Model Number3000-10-28161412
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
HIBCCM970300010281614120 [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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00810028396005 - Half pin - 5 x 180mm with 50mm thread, stepped tip2024-07-17

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