Precision Screw CRY01-H4-1E

GUDID 09351290000081

CRYPTYCH PTY LTD

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 09351290000081
• NIH Device Record Key: c65f633e-beda-4070-bd1e-cdbe0bea5489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Screw
• Version Model Number: CRY01-H4-1E
• Catalog Number: CRY01-H4-1E
• Company DUNS: 742846228
• Company Name: CRYPTYCH PTY LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	09351290000081 [Primary]
GS1	19351290000088 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160385

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-12-10

On-Brand Devices [Precision Screw]

• 09351290000081: CRY01-H4-1E
• 09351290000074: CRY01-H3-1E