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

GUDID 00810563022032

ENDOCARE, INC.

Cryosurgical set
Primary Device ID00810563022032
NIH Device Record Keyeafe1d89-5dc8-4427-a1a9-24034fb6de6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal
Version Model NumberPC-2.1E
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
GS100810563022032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

Radiation Sterilization

[00810563022032]

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.

00810563022278 - IntelliBlate Microwave Ablation System Console2024-08-19 IntelliBlate microwave ablation system console only for tabletop configuration
00810563022285 - IntelliBlate Microwave Ablation System Mobile Cart2024-08-19 Mobile cart only for IntelliBlate microwave ablation system
10810563022299 - IntelliBlate Ximitry Probe Assembly, 13G x 15cm2024-08-19 IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G
10810563022305 - IntelliBlate Ximitry Probe Assembly, 13G x 20cm2024-08-19 IntelliBlate Ximitry probe assembly includes cassette with saline tubing, Ximitry laser alignment disc, and microwave ablation p
10810563022312 - IntelliBlate Ximitry Probe Assembly, 13G x 27cm2024-08-19 IntelliBlate Ximitry probe assembly includes cassette with saline tubing, laser alignment disc, and microwave ablation probe 13G
10810563022329 - Temperature Sensor Probe, 18G x 20cm2024-08-19 Ablation accessory: disposable temperature probe, 18G/20cm Probe QTY 1
00810563022032 - ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal2023-04-28
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.