Lithotomy Drape FG351101

GUDID 10860009122939

PROCEPT BIOROBOTICS CORPORATION

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• Primary Device ID: 10860009122939
• NIH Device Record Key: cf470c15-abb7-44ba-b91a-74adaabd7755
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lithotomy Drape
• Version Model Number: FG351101
• Catalog Number: FG351101
• Company DUNS: 016646472
• Company Name: PROCEPT BIOROBOTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com
• Phone: +1(650)232-7222
• Email: customerservice@procept-biorobotics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009122932 [Primary]
GS1	10860009122939 [Package]; Contains: 00860009122932; Package: Shipper Box [8 Units]; In Commercial Distribution
HIBCC	B6143511011 [Previous]

FDA Product Code

• EYY: Drape, urological, disposable

Sterilization

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

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

[10860009122939]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

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