TIGER SHARK

GUDID 00840996185684

TIGER SHARK,NERVE RETRACTOR,TALL DOUBLE

Choice Spine, LP

Metallic spinal interbody fusion cage

• Primary Device ID: 00840996185684
• NIH Device Record Key: 770d6fdf-2843-46a6-8e2e-1fce74e2c159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIGER SHARK
• Version Model Number: P070-1015
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: true
• 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	00840996185684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171456

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

[00840996185684]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [TIGER SHARK]

• 00840996193078: TLIF,FORWARD BAYONETTED CUP CURRETTE,#2
• 00840996193061: TLIF,STRAIGHT BAYONETTED CUP CURETTE,#2
• 00840996193047: TIGERSHARK M,MODULAR FUNNEL ATTACHMENT
• 00840996193030: TIGERSHARK M,MODULAR GRAFT FUNNEL SHAFT
• 00840996193023: TIGERSHARK THREADED TL, TAMP
• 00840996192897: TLIF,BAYONET RETRACTOR - 5MM
• 00840996192880: TLIF,STRAIGHT BAYONETED BOX CURETTE
• 00840996192729: TIGERSHARK M,REMOVAL FORK
• 00840996192552: TLIF,DOWN ANGLED BAYONETED BOX CURRETTE
• 00840996192545: TLIF,UP ANGLED BAYONETED BOX CURRETTE
• 00840996192538: TIGERSHARK M,4-8H LOCKING ROD
• 00840996192521: TIGERSHARK M,2-3H LOCKING ROD
• 00840996192484: TLIF,PITUITARY,BAYONETED,UP,4MM
• 00840996192477: TLIF,PITUITARY,BAYONETED,UP,3MM
• 00840996192460: TLIF,PITUITARY,BAYONETED,UP,1MM
• 00840996192453: TLIF,KERRISON,BAYONETED,3MM
• 00840996192446: TLIF,KERRISON,BAYONETED,1MM
• 00840996192385: TIGERSHARK,TEARDROP CURETTE,25 DEG
• 00840996192378: TIGERSHARK,TEARDROP CURETTE,15 DEG
• 00840996189361: TIGERSHARK,NERVE RETRACTOR,TALL
• 00840996189354: PLI,PURPLE HANDLE INSERTER
• 00840996189347: TLIF,SCALPEL HANDLE,BAYONETED
• 00840996189330: TLIF,CURETTE,BAYONETED,45DEG OFFSET,DWN
• 00840996189323: TLIF,CURETTE,BAYONETED,45DEG OFFSET,UP
• 00840996189316: TLIF,CURETTE,TEARDROP,BAYONETED 5DEG,#3
• 00840996189309: TLIF,CURETTE,TEARDROP,BAYONETED 15DEG,#3
• 00840996189293: TLIF,CURETTE,TEARDROP,BAYONETED 30DEG,#3
• 00840996189286: TLIF,WOODSON,BAYONETED
• 00840996189279: TLIF,PENFIELD,PUSH,BAYONETED
• 00840996189262: TLIF,NERVE HOOK,BAYONETED
• 00840996189255: TLIF,CURETTE,BAYONETED,LARGE
• 00840996189248: TLIF,CURETTE,BAYONETED,SMALL
• 00840996189231: TLIF,CURETTE,STRAIGHT,ANGLED BACK,#4
• 00840996189224: TLIF,CURETTE,BAYONETED,LARGE,ANGLED
• 00840996189217: TLIF,CURETTE,BAYONETED,SMALL,ANGLED
• 00840996189200: TLIF,CURETTE,BAYONETED,STRAIGHT,LARGE
• 00840996189194: TLIF,CURETTE,BAYONETED,STRAIGHT,SMALL
• 00840996189187: TLIF,PITUITARY,BAYONETED,UP,2MM
• 00840996189170: TLIF,PITUITARY,BAYONETED,STRAIGHT,4MM
• 00840996189163: TLIF,PITUITARY,BAYONETED,STRAIGHT,2MM
• 00840996189156: TLIF,KERRISON,BAYONETED,4MM
• 00840996189149: TLIF,KERRISON,BAYONETED,2MM
• 00840996189132: TIGERSHARK M,STATIC TRIAL,16HX12DEG
• 00840996189125: TIGERSHARK M,STATIC TRIAL,15HX12DEG
• 00840996189118: TIGERSHARK M,STATIC TRIAL,14HX12DEG
• 00840996189101: TIGERSHARK M,STATIC TRIAL,1HX12DEG
• 00840996189095: TIGERSHARK M,STATIC TRIAL,12HX12DEG
• 00840996189088: TIGERSHARK M,STATIC TRIAL,11HX12DEG
• 00840996189071: TIGERSHARK M,STATIC TRIAL,10HX12DEG
• 00840996189064: TIGERSHARK M,STATIC TRIAL,15HX6DEG