ANAX™ 5.5 CT Spinal System

GUDID 08800037572080

U&I CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800037572080
• NIH Device Record Key: 3f9b9f15-f401-4b38-ab29-5d9459cae6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAX™ 5.5 CT Spinal System
• Version Model Number: CTC7625
• Company DUNS: 688811082
• Company Name: U&I CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: true
• 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	08800037572080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181824

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

[08800037572080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-18
• Device Publish Date: 2022-07-08

On-Brand Devices [ANAX™ 5.5 CT Spinal System]

• 08800037523976: CT0924
• 08800037523969: CT0120
• 08800037523952: CT0100
• 08800037523945: CT0090
• 08800037523938: CT0030
• 08800037524003: CTS0010
• 08800037524010: CTS0090
• 08800037524058: CTS0080
• 08800037500656: CT0100
• 08800015999939: CT0120
• 08800015999861: CT0020
• 08800037527660: CT0080
• 08800037542731: CTS0100
• 08800037544704: CT0130
• 08800037501882: CT0916
• 08800037501875: CT0915
• 08800037501868: CT0914
• 08800037501851: CT0913
• 08800037501844: CT0912
• 08800037501837: CT0911
• 08800037501820: CT0910
• 08800037500816: CT0934
• 08800037500809: CT0933
• 08800037500793: CT0932
• 08800037500786: CT0931
• 08800037500779: CT0930
• 08800037500762: CT0924
• 08800037500755: CT0923
• 08800037500748: CT0922
• 08800037500731: CT0921
• 08800037500724: CT0920
• 08800037545374: ML0120WR
• 08800037545367: ML0120WL
• 08800037545350: ML0120NR
• 08800037545343: ML0120NL
• 08800037545336: ML0110WR
• 08800037545329: ML0110WL
• 08800037545312: ML0110NR
• 08800037545305: ML0110NL
• 08800037545299: ML0100WR
• 08800037545282: ML0100WL
• 08800037545275: ML0100NR
• 08800037545268: ML0100NL
• 08800037545251: ML0090WR
• 08800037545244: ML0090WL
• 08800037545237: ML0090NR
• 08800037545220: ML0090NL
• 08800037545213: ML0080WR
• 08800037545206: ML0080WL
• 08800037545190: ML0080NR