ASY-00720

GUDID 00810045534572

Rocker 5.5/6.0mm Tulip- Extended Window

INTEGRITY IMPLANTS INC.

Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer Orthopaedic rod reducer

• Primary Device ID: 00810045534572
• NIH Device Record Key: 9aea4f50-7212-4eaa-be07-5790f829ee40
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ASY-00720
• Catalog Number: ASY-00720
• Company DUNS: 080300717
• Company Name: INTEGRITY IMPLANTS INC.
• 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: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]
GS1	00810045534572 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

[00810045534572]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-13
• Device Publish Date: 2021-01-05

Devices Manufactured by INTEGRITY IMPLANTS INC.

• 00840200403160 - NA: 2021-01-18 Anti-Splay Cap, 5.5 -6.0
• 00810045534572 - NA: 2021-01-13Rocker 5.5/6.0mm Tulip- Extended Window
• 00810045534572 - NA: 2021-01-13 Rocker 5.5/6.0mm Tulip- Extended Window
• 00810004729018 - NA: 2020-12-24 Expandable Shaver, FH7
• 00810004729025 - NA: 2020-12-24 Shaver Blade Assembly
• 00810004729421 - N/A: 2020-12-23 Small Curette
• 00810004729445 - N/A: 2020-12-23 Large Curette
• 00810004729452 - N/A: 2020-12-23 Small Up Curette
• 00810004729476 - N/A: 2020-12-23 Large Up Curette