PROSTAGRIP™ 081358

GUDID 10850012846335

PROSTAGRIP™ DEVICE

LSI Solutions, Inc.

Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use Urethral dilator, single-use

• Primary Device ID: 10850012846335
• NIH Device Record Key: fa53be14-14c4-48d1-8718-22ee9d8188c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROSTAGRIP™
• Version Model Number: 081358
• Catalog Number: 081358
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• 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: true
• 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(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846338 [Primary]
GS1	10850012846335 [Package]; Contains: 00850012846338; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• FBX: SOUND, URETHRAL, METAL OR PLASTIC

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: 2024-04-29
• Device Publish Date: 2024-04-19

Devices Manufactured by LSI Solutions, Inc.

• 10850012846335 - PROSTAGRIP™: 2024-04-29PROSTAGRIP™ DEVICE
• 10850012846335 - PROSTAGRIP™: 2024-04-29 PROSTAGRIP™ DEVICE
• 10850012846281 - VIRTUOSEW™: 2024-02-22 VIRTUOSEW™ DEVICE
• 10850012846298 - AVR NAVIGATOR™: 2024-02-12 AVR NAVIGATOR™ SMALL RETRACTOR WITH DELIVERY DEVICE
• 10850012846304 - AVR NAVIGATOR™: 2024-02-12 AVR NAVIGATOR™ MEDIUM RETRACTOR WITH DELIVERY DEVICE
• 10850012846311 - AVR NAVIGATOR™: 2024-02-12 AVR NAVIGATOR™ LARGE RETRACTOR WITH DELIVERY DEVICE
• 00850012846321 - miniARM® multiSTATION™ System: 2024-01-11 BITA RetroSterno™ Paddle
• 10850012846267 - AnastoPod™: 2023-07-31 AnastoPod™ DEVICE
• 10850012846007 - PNEUMOSTOP®: 2022-11-14 PNEUMOSTOP® DEVICE