Screw Caddy

GUDID 09348215066376

SIGNATURE ORTHOPAEDICS PTY LTD

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Primary Device ID	09348215066376
NIH Device Record Key	7528345d-5581-4592-bd1a-003b24ce0854
Commercial Distribution Status	In Commercial Distribution
Brand Name	Screw Caddy
Version Model Number	PS2-08-0050
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
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	false
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	09348215066376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163625

FDA Product Code

KWQ	Appliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

[09348215066376]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-07-03
Device Publish Date	2020-06-25

On-Brand Devices [Screw Caddy]

09348215066376	PS2-08-0050
09348215066949	132-16-0039

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