DePuy Synthes VELYS 4515-70-008

GUDID 00748426124886

VELYS Device Sterile Drape_EO_20CS

Microtek Medical Inc.

Medical equipment drape, single-use

• Primary Device ID: 00748426124886
• NIH Device Record Key: 83cc4ed6-83ec-4c9d-a562-d4606fce034a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DePuy Synthes VELYS
• Version Model Number: 451570008
• Catalog Number: 4515-70-008
• Company DUNS: 106908437
• Company Name: Microtek Medical 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748426124886 [Primary]
GS1	50748426124881 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

[00748426124886]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

On-Brand Devices [DePuy Synthes VELYS]

• 00748426124909: VELYS Satellite Station Drape_EO_20CS
• 00748426124886: VELYS Device Sterile Drape_EO_20CS
• 50748426130110: VELYS™ Satellite Station Drape
• 00748426130092: VELYS Device Sterile Drape