Response Spine System 03-1300-0005-ATL-1

GUDID 00840194493574

Atlanta Prep – Tray 1

ORTHOPEDIATRICS CORP.

Instrument tray, reusable

• Primary Device ID: 00840194493574
• NIH Device Record Key: 2af730ac-ce74-4cdb-9e41-2829dc73d970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Response Spine System
• Version Model Number: 03-1300-0005-ATL-1
• Catalog Number: 03-1300-0005-ATL-1
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194493574 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

[00840194493574]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

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