N/A CRYO-48

GUDID 00810563020106

Endocare™ 8mm Cryoprobe

ENDOCARE, INC.

Cryosurgical set
Primary Device ID00810563020106
NIH Device Record Keyae0454ff-8abc-4c69-b4c2-795bfb40ddeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberCRYO-48
Catalog NumberCRYO-48
Company DUNS928955509
Company NameENDOCARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx
Phone5123282892
Emailxx@xx.xx

Device Dimensions

Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810563020106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-31

On-Brand Devices [N/A]

00810563020427Endocare™ Prostate Procedure Probe Pack 4 x CVA2400 6 x CRYO-55-F 1 x CRYO-77
00810563020397Endocare™ Prostate Procedure Probe Pack 6 x CVA2400 6 x CRYO-55-F 1 x CRYO-77
00810563020380Endocare™ Urethral Warming Catheter Kit
00810563020342Endocare™ Urethral Warming System
00810563020106Endocare™ 8mm Cryoprobe

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