Prostate Procedure Template SPR000018

GUDID 07290104830525

Prostate Procedure Template for use with Galil Medical 1.5 mm Shaft Diameter Cryoablation Needles

GALIL MEDICAL LTD

Cryosurgical set

• Primary Device ID: 07290104830525
• NIH Device Record Key: db38c5cd-8ada-4364-8146-23bc55a03170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prostate Procedure Template
• Version Model Number: SPR000018
• Catalog Number: SPR000018
• Company DUNS: 531854560
• Company Name: GALIL MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com
• Phone: 651-287-5000
• Email: galil.cst@btgplc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
• Special Storage Condition, Specify: Between 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290104830525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010991

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

[07290104830525]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-15

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