ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical

GUDID 00810563022049

ENDOCARE, INC.

Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set Cryosurgical set
Primary Device ID00810563022049
NIH Device Record Keybdb2373d-dc3b-4fcf-80cd-262b1076f871
Commercial Distribution StatusIn Commercial Distribution
Brand NameISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical
Version Model NumberPC-2.1S
Company DUNS928955509
Company NameENDOCARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810563022049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

[00810563022049]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-28
Device Publish Date2023-04-20

Devices Manufactured by ENDOCARE, INC.

00810563022032 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal2023-04-28
00810563022049 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical2023-04-28
00810563022049 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Spherical2023-04-28
00810563022056 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Ellipsoidal2023-04-28
00810563022063 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, Spherical2023-04-28
00810563020977 - Urethral Warming Catheter Kit2022-02-11 Urethral Warming catheter for use in tissue warmning during cryosurgical procedures with the Cryocare systems
00810563020649 - Varian CRYOCARE TOUCH™ System2020-08-24
00810563020595 - SynchroWave Antenna Kit2020-01-09 15cm Short Tip Antenna and Cooling Circuit
00810563020540 - SynchroWave Antenna Kit2020-01-09 20cm Long Tip Antenna and Cooling Circuit
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.