PNEUMOSTOP® 110200

GUDID 10850012846007

PNEUMOSTOP® DEVICE

LSI Solutions, Inc.

Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder Laparoscopic hysterectomy vaginal occluder

• Primary Device ID: 10850012846007
• NIH Device Record Key: 4f7f75c6-b74b-43af-a2c4-e98d57c135d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUMOSTOP®
• Version Model Number: 110200
• Catalog Number: 110200
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 3
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846000 [Primary]
GS1	00850200006742 [Previous]
GS1	10850012846007 [Package]; Contains: 00850012846000; Package: Case [6 Units]; In Commercial Distribution
GS1	40850012846008 [Unit of Use]

FDA Product Code

• NWW: Hysteroscope accessories

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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [PNEUMOSTOP®]

• 10850200006756: PNEUMOSTOP® PLUS DEVICE Each sterile pouch contains one single patient use PNEUMOSTOP® PLUS DE
• 10850200006749: PNEUMOSTOP® DEVICE Each sterile pouch contains one single patient use PNEUMOSTOP® DEVICE.
• 10850012846014: PNEUMOSTOP® PLUS DEVICE
• 10850012846007: PNEUMOSTOP® DEVICE