Primary Device ID | M97030000400000 |
NIH Device Record Key | 158f6363-633f-4585-ad85-46cab7b56eb4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DynaClip Forte |
Version Model Number | 3000-04-000 |
Company DUNS | 601306413 |
Company Name | Medshape, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M97030000400000 [Primary] |
KDD | Kit, Surgical Instrument, Disposable |
Steralize Prior To Use | true |
Device Is Sterile | true |
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
[M97030000400000]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-08-12 |
Device Publish Date | 2020-05-14 |
M9703000062620200 | DynaClip Forte Bone Fixation System, 26mm x 20mm x 20mm |
M9703000063020200 | DynaClip Forte Bone Fixation System, 30mm x 20mm x 20mm |
M97030000400000 | DYNACLIP PROCEDURE PACK, 4-LEG |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DYNACLIP FORTE 88858769 not registered Live/Pending |
MedShape, Inc. 2020-04-03 |
![]() DYNACLIP FORTE 88719509 not registered Live/Pending |
MedShape, Inc. 2019-12-09 |