Infab D-1001

GUDID 16975085708282

C-Arm Drape 104x188cm-41"x74"

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 16975085708282
• NIH Device Record Key: 4ce578ac-067d-42e0-9b3e-4e1b1d1a20d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infab
• Version Model Number: D-1001
• Catalog Number: D-1001
• 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	06975085708285 [Primary]
GS1	16975085708282 [Package]; Contains: 06975085708285; Package: Inner Case [15 Units]; In Commercial Distribution
GS1	26975085708289 [Package]; Package: Case [2 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: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [Infab]

• 26975085709163: C-Arm Drape-Mini 137x160cm - 54"x63"
• 26975085708302: C-Arm Drape w/ Clips, Band Bags and Foot Pedal Drape12" Imag
• 16975085708282: C-Arm Drape 104x188cm-41"x74"