Response Spine System 01-1300-8261

GUDID 00840194462679

Luer Lock Cannulated Tap

ORTHOPEDIATRICS CORP.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 00840194462679
• NIH Device Record Key: 28127fd7-b8aa-4f77-b5f0-8f80965ef0b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response Spine System
• Version Model Number: 01-1300-8261
• Catalog Number: 01-1300-8261
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• 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: 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	00840194462679 [Primary]

FDA Product Code

• HWX: TAP, BONE

Sterilization

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

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

[00840194462679]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-26
• Device Publish Date: 2024-02-16

On-Brand Devices [Response Spine System]

• 00841132177471: 5.5/6.0 Polyaxial Caddy 1
• 00841132177563: 5.5/6.0 Correction - Tray 2
• 00841132177556: 5.5/6.0 Correction - Tray 1
• 00841132177549: 5.5/6.0 Set Screw Caddy
• 00841132177532: Response 4.5/5.0 Dual Set Screw Driver
• 00841132177525: 5.5/6.0 Rod & Rod Reduction - Tray 1
• 00841132177518: 6.0MM TAP, 25MM LENGTH, HUDSON
• 00841132177358: 6.0mm Cannulated Tap, Double Lead, Square
• 00841132177341: 5.5mm Cannulated Tap, Double Lead, Square
• 00841132177297: Reduction Tab Breaker
• 00841132177280: Lenke Probe, Handle
• 00841132177273: 4.5/5.0 Rowe Poly Reduction Case
• 00841132177266: 5.5/6.0 Rowe Poly Reduction Case
• 00841132177181: 1/4 Drive Modular Lenke Probe
• 00841132176856: 5.5/6.0 Hook & Connector - Hook Caddy
• 00841132176849: 5.5/6.0 Hook & Connector - Connector Caddy
• 00841132176832: 5.5/6.0 Hook & Connector - Tray 2
• 00841132176825: 5.5/6.0 Hook & Connector - Tray 1
• 00841132176818: 5.5/6.0 Correction - Tray 2
• 00841132176801: 5.5/6.0 Correction - Tray 1
• 00841132176795: 5.5/6.0 Set Screw Caddy
• 00841132176788: 5.5/6.0 Rod & Rod Reduction - Tray 2
• 00841132176771: 5.5/6.0 Rod & Rod Reduction - Tray 1
• 00841132176764: 5.5/6.0 Pedicle Prep & Final Drive - Tray 3
• 00841132176757: 5.5/6.0 Pedicle Prep & Final Drive - Tray 2
• 00841132176740: 5.5/6.0 Pedicle Prep & Final Drive - Tray 1
• 00841132176733: 5.5/6.0 Polyaxial Caddy 2
• 00841132176726: 5.5/6.0 Polyaxial Caddy 1
• 00841132176719: 5.5/6.0 Uniaxial Caddy 2
• 00841132176702: 5.5/6.0 Uniaxial Caddy 1
• 00841132176597: PEDICLE MARKER, MOD 30MM
• 00841132176580: PEDICLE MARKER, MOD 15MM
• 00841132175675: Hourglass Feeler Probe, Large
• 00841132175668: Hourglass Feeler Probe, Small
• 00841132175651: Hourglass Feeler Probe, Double
• 00841132174425: Final Torque, Short, Power
• 00841132173480: 6.0mm Solid Tap, Double Lead, Power
• 00841132173473: 5.0mm Solid Tap, Double Lead, Power
• 00841132173466: 4.0mm Solid Tap, Double Lead, Power
• 00841132173459: 3.0mm Solid Tap, Double Lead, Power
• 00841132156490: JIMINY DRIVER, MEDIUM
• 00841132156476: 6.0mm Solid Tap, Single Lead, Power
• 00841132156469: 5.5mm Solid Tap, Single Lead, Power
• 00841132156452: 5.0mm Solid Tap, Single Lead, Power
• 00841132156445: 4.5mm Solid Tap, Single Lead, Power
• 00841132156438: 4.0mm Solid Tap, Single Lead, Power
• 00841132156421: 3.5mm Solid Tap, Single Lead, Power
• 00841132156414: 3.0mm Solid Tap, Single Lead, Power
• 00841132156407: 6.0mm Solid Tap, Single Lead, Square
• 00841132156391: 5.5mm Solid Tap, Single Lead, Square