Tzoar

GUDID 10850017034102

Tzoar NPWT OPD - Square 2020

LIGHTSTONE MEDICAL LLC

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 10850017034102
• NIH Device Record Key: de8c7c4f-d20f-4c2d-b9e5-a3fcbb49163c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tzoar
• Version Model Number: LSM-SQ-2020
• Company DUNS: 126892971
• Company Name: LIGHTSTONE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017034105 [Primary]
GS1	10850017034102 [Package]; Contains: 00850017034105; Package: [5 Units]; In Commercial Distribution
GS1	20850017034109 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202898

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

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: 2023-10-16
• Device Publish Date: 2023-10-06

On-Brand Devices [Tzoar]

• 10850017034171: Tzoar 207 400cc Canister
• 10850017034140: Tzoar NPWT OPD - Square 1010
• 10850017034102: Tzoar NPWT OPD - Square 2020
• 10850017034096: Tzoar NPWT OPD - Small Oval 1008
• 10850017034089: Tzoar NPWT OPD - Sacrum 1312
• 10850017034072: Tzoar NPWT OPD - Square 1515
• 10850017034065: Tzoar NPWT OPD - Large Oval 1410
• 10850017034058: Tzoar NPWT OPD - Rectangular 2207
• 10850017034041: Tzoar One Adhesive Drape
• 10850017034034: Tzoar NPWT Foam Kit - Small
• 10850017034027: Tzoar NPWT Foam Kit - Medium
• 10850017034010: Tzoar NPWT Foam Kit - Large
• 00850017034006: Tzoar 207 NPWT Pump