CIV-Flex™ Guide Sheath SH-01

GUDID 00841436120951

SCOUT Guide Sheath for use with SCOUT Surgical Guidance System

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover
Primary Device ID00841436120951
NIH Device Record Key9e13cff3-41e7-4596-8705-8416e266ecdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCIV-Flex™ Guide Sheath
Version Model NumberSH-01
Catalog NumberSH-01
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter
Width8.3 Centimeter
Length264 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436120951 [Package]
Contains: 10841436120958
Package: [20 Units]
In Commercial Distribution
GS110841436120958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

[00841436120951]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-29
Device Publish Date2021-01-21

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