HLS Plate, T-Shape 21501

GUDID 09120047304877

HLS Plate, T-Shape, Extended

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

Primary Device ID	09120047304877
NIH Device Record Key	472d7cc6-72e2-41f4-b2e1-ff276aac0647
Commercial Distribution Status	In Commercial Distribution
Brand Name	HLS Plate, T-Shape
Version Model Number	21501
Catalog Number	21501
Company DUNS	303456917
Company Name	I.T.S. GmbH
Device Count	1
DM Exempt	true
Pre-market Exempt	true
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	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120047304877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142418

FDA Product Code

HRS	Plate, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

[09120047304877]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2024-08-07
Device Publish Date	2016-09-12

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