N/A ASY-01117

GUDID 00840200409612

Disc Wedge - 12mm

Integrity Implants Inc.

Orthopaedic surgical distractor, internal

• Primary Device ID: 00840200409612
• NIH Device Record Key: cc4a0d27-d8db-4eba-baa8-bc66c6f9f967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: ASY-01117
• Catalog Number: ASY-01117
• 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: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840200409612 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

[00840200409612]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

On-Brand Devices [N/A]

• 00810004722323: FlareHawk Universal Instrument Tray
• 00810004721883: Pedicle Rod Inserter
• 00810004721746: Handled Double Ended Set Screw Starter
• 00810004721739: Self Retaining Screw Driver - Split Ring Style
• 00818613027327: 15mm Distractor
• 00818613027310: 14mm Distractor
• 00818613027303: 13mm Distractor
• 00818613027297: 12mm Distractor
• 00818613027280: 11mm Distractor
• 00818613027273: 10mm Distractor
• 00818613027266: 9mm Distractor
• 00818613027259: 8mm Distractor
• 00818613027242: 7mm Distractor
• 00818613021547: Lateral Curette, Ring Size #3 Up Angled Curette, Ring Size #3
• 00818613021530: Straight Curette, Ring Size #3 Up Angled Curette, Ring Size #3
• 00818613021523: Down Pushing Curette Up Angled Curette, Ring Size #3
• 00818613021516: Up Angled Curette, Ring Size #3 Up Angled Curette, Ring Size #3
• 00818613021455: VS Bone Funnel
• 00818613021448: VS Bone Tamp
• 00818613021257: Tall Obturator Impactor
• 00818613021240: Short Obturator Impactor
• 00818613021172: Implant Tamp
• 00818613021141: 16cm Offset Graft Guide
• 00818613021134: 16cm Straight Graft Guide
• 00818613021066: Straight Rasp
• 00818613021059: 30 Degree Bent Rasp
• 00818613021035: Tall Cannula
• 00818613021028: Short Cannula
• 00818613021011: 3.25mm Rasp
• 00818613020946: CMP-00043 GB Impactor
• 00818613020922: CMP-00023 GB Cannula Tall
• 00818613020915: GB Cannula Short
• 00818613020908: CMP-00021 GB Dilator 2, Tall
• 00818613020892: CMP-00020 GB Dilator 2, Short
• 00818613020885: GB Dilator 1
• 00818613020878: Shaver, 14mm
• 00818613020861: Shaver, 13mm
• 00818613020854: Shaver, 12mm
• 00818613020847: Shaver, 11mm
• 00818613020830: Shaver, 10mm
• 00818613020823: Shaver, 9mm
• 00818613020816: Shaver, 8mm
• 00818613020809: Shaver, 7mm
• 00818613020601: Split Shim Removal Tool
• 00818613020502: CR 9.5MM ANGLED UTERINE CURETTE (Ring Curette)
• 00818613020496: Distractor size 14mm
• 00818613020489: Distractor size 13mm
• 00818613020472: Distractor size 12mm
• 00818613020465: Distractor size 11mm