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 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 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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