TIGER SHARK C

GUDID 00840996181815

TIGER SHARK C, PADDLE DISTRACTOR, 14MM

Choice Spine, LP

Metallic spinal interbody fusion cage

Primary Device ID	00840996181815
NIH Device Record Key	9d35f8b2-cd2c-4766-908b-21aead84e6f6
Commercial Distribution Status	In Commercial Distribution
Brand Name	TIGER SHARK C
Version Model Number	D070-0014
Company DUNS	078293017
Company Name	Choice Spine, LP
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	00840996181815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183397

FDA Product Code

LXH	Orthopedic manual surgical instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

[00840996181815]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-03-04
Device Publish Date	2024-02-24

On-Brand Devices [TIGER SHARK C]

00840996181815	TIGER SHARK C, PADDLE DISTRACTOR, 14MM
00840996181273	TIGER SHARK C TAMP, U-STOP

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