CURE ACP

GUDID B167700436000

MEDITECH SPINE, LLC

Bone tap, reusable

• Primary Device ID: B167700436000
• NIH Device Record Key: 3207089e-bdda-4c3e-b443-f5526d7b83e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE ACP
• Version Model Number: 700-436-00
• Company DUNS: 182698477
• Company Name: MEDITECH SPINE, LLC
• Device Count: 1
• DM Exempt: false
• 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
HIBCC	B167700436000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160604

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

[B167700436000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-30

On-Brand Devices [CURE ACP]

• B167S1700435100: S1-700-435-10
• B167S1700430200: S1-700-430-20
• B167S1700430180: S1-700-430-18
• B167S1700430160: S1-700-430-16
• B167S1700430140: S1-700-430-14
• B167S1700430120: S1-700-430-12
• B167S1700430100: S1-700-430-10
• B167900430600: 900-430-60
• B167900430550: 900-430-55
• B167900430500: 900-430-50
• B167900430450: 900-430-45
• B167900430400: 900-430-40
• B167900430350: 900-430-35
• B167900430300: 900-430-30
• B167900430250: 900-430-25
• B167900430200: 900-430-20
• B167700455000: 700-455-00
• B167700436000: 700-436-00
• B167700435100: 700-435-10
• B167700430200: 700-430-20
• B167700430180: 700-430-18
• B167700430160: 700-430-16
• B167700430140: 700-430-14
• B167700430120: 700-430-12
• B167700430100: 700-430-10