Globus Medical, Inc. 6221.2070S

GUDID 16975424192833

ExcelsiusFLEX™-TKA Drape

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 16975424192833
• NIH Device Record Key: 982af8b1-db48-45a2-8f2a-969df3235ba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Globus Medical, Inc.
• Version Model Number: 6221.2070S
• Catalog Number: 6221.2070S
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• 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: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424192836 [Primary]
GS1	16975424192833 [Package]; Contains: 06975424192836; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	26975424192830 [Package]; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

On-Brand Devices [Globus Medical, Inc.]

• 16975424192833: ExcelsiusFLEX™-TKA Drape
• 26975424192564: Drape, ExcelsiusHub™ Skirt, GNS
• 26975424192540: Drape, ExcelsiusHub™ Monitor, GNS