Block/Spacer - 100mm

GUDID 00810028396319

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00810028396319
NIH Device Record Key412a296c-f391-4834-be2f-17be28b811de
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlock/Spacer - 100mm
Version Model NumberDNE-6000-001
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028396319 [Primary]

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


[00810028396319]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-07-09
Device Publish Date2024-05-31

Devices Manufactured by Medshape, Inc.

M97015000009200 - Eclipse2025-08-19 ECLIPSE, 9MM X 20MM
M97029002402500 - DynaNail Mini2025-08-14 CONNECTION SCREW, M2.5, DYNANAIL MINI
M97015000400000 - Eclipse2025-08-13 Tendon Spear, ExoShape Tenodesis
M97022001100010 - DynaNail2025-08-13 Inline Ratchet Driver, DynaNail
M97022002900000 - DynaNail2025-08-13 FRAME ASSEMBLY, CF, DYNANAIL
M97022010900400 - DynaNail2025-08-13 Drill, 4.0mm x 15cm, Dynanail
M9702300010500 - Eclipse2025-08-13 Acorn Reamer, 5.00mm
M9702300010550 - Eclipse2025-08-13 Acorn Reamer, 5.50mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.