Primary Device ID | 10724995199217 |
NIH Device Record Key | 11bad5d3-5118-4872-b352-413f7702f69e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | truFreeze |
Version Model Number | 2000181 |
Catalog Number | 2000181 |
Company DUNS | 627879687 |
Company Name | US Endoscopy |
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 | true |
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 |
Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Phone | +1(800)548-4873 |
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Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00724995199210 [Primary] |
GS1 | 00857068006075 [Previous] |
GS1 | 10724995199217 [Package] Contains: 00724995199210 Package: Case [5 Units] In Commercial Distribution |
GEH | UNIT, CRYOSURGICAL, ACCESSORIES |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-05-12 |
Device Publish Date | 2022-05-04 |
10724995199231 | The Vortex Spray Kit is for use as a cryosurgical tool to ablate benign lesions (e.g., Barrett's |
10724995199330 | Rapid AV Active Venting Cathether is used with the truFreeze Spray Cryotherapy System. |
10724995199323 | Rapid AV Catheter Kit with 16 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introd |
10724995199286 | truFreeze Aire PV Passive Venting Catheter Kit includes 7 Fr Catheter, Straight Spray Catheter |
10724995199224 | Rapid AV Catheter Kit with 20 FR CDT includes 2.1mm Catheter (Straight Spray), Catheter Introduc |
10724995199217 | 16 FR CryoDecompression Tube (CDT) - Low Durometer is used with the truFreeze Spray Cryotherapy |
10724995199200 | 20 FR CryoDecompression Tube (CDT) Active Venting is used with the truFreeze Spray Cryotherapy |
00724995199296 | truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during b |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TRUFREEZE 77813346 3891062 Live/Registered |
CSA MEDICAL, INC. 2009-08-26 |
![]() TRUFREEZE 77813330 3891061 Live/Registered |
CSA MEDICAL, INC. 2009-08-26 |