Lithotomy Drape 351101

GUDID B6143511011

The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The

PROCEPT BIOROBOTICS CORPORATION

Patient surgical drape, single-use, sterile

• Primary Device ID: B6143511011
• NIH Device Record Key: 9120a126-3cda-4101-8b43-c52f611decae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lithotomy Drape
• Version Model Number: 351101
• Catalog Number: 351101
• Company DUNS: 016646472
• Company Name: PROCEPT BIOROBOTICS CORPORATION
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6143511011 [Primary]
HIBCC	B6143511012 [Package]; Package: [8 Units]; In Commercial Distribution
HIBCC	B6143511018 [Package]; Package: [8 Units]; Discontinued: 2018-01-11; Not in Commercial Distribution

FDA Product Code

• EYY: Drape, Urological, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2017-12-06

On-Brand Devices [Lithotomy Drape]

• B6143511011: The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barri
• 10860009122939: FG351101
• 00850055427044: FG351101