Proficient Surgical

GUDID 16975424198729

INTRAOPERATIVE PROBE DRAPE, 5” X 96"

EXACT MEDICAL MANUFACTURING, INC.

Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 16975424198729
• NIH Device Record Key: 68740baf-184a-4a90-920a-0ee6e4e612cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proficient Surgical
• Version Model Number: PS2037
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424198722 [Primary]
GS1	16975424198729 [Package]; Contains: 06975424198722; Package: Inner Case [20 Units]; In Commercial Distribution
GS1	26975424198726 [Package]; Package: Case [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222460

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2026-03-19
• Device Publish Date: 2026-03-11

On-Brand Devices [Proficient Surgical]

• 16975424198736: DELUXE VIDEO CAMERA DRAPE, 7” X 96"
• 16975424198729: INTRAOPERATIVE PROBE DRAPE, 5” X 96"