Washer - Slotted

GUDID 00810028397200

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable

Primary Device ID	00810028397200
NIH Device Record Key	de5e95ce-91fd-447c-a969-8aaead07f1d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Washer - Slotted
Version Model Number	DNE-6000-033
Company DUNS	601306413
Company Name	Medshape, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810028397200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113106

FDA Product Code

KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

[00810028397200]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-06-10
Device Publish Date	2024-05-31

On-Brand Devices [Washer - Slotted]

00810028397200	DNE-6000-033
00810028397248	DNE-6000-033

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