Surgi Transducer Cover 610-023

GUDID 00841436101394

Sterile (15.2 tapered to 7.6 x 244cm) accordion-folded polyethylene cover and (14 x 30cm) CIV-Flex™ cover (no gel)

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

Primary Device ID	00841436101394
NIH Device Record Key	c0bb3cac-92c0-497d-8dfa-a35b887dd40e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Surgi Transducer Cover
Version Model Number	610-023
Catalog Number	610-023
Company DUNS	134614411
Company Name	CIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
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	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com

Device Dimensions

Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch
Length	5.2 Inch
Height	0.91 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436101394 [Package] Contains: 10841436101391 Package: [12 Units] In Commercial Distribution
GS1	10841436101391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K970514

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

[00841436101394]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-10-07
Device Publish Date	2017-08-22

On-Brand Devices [Surgi Transducer Cover]

00841436101394	Sterile (15.2 tapered to 7.6 x 244cm) accordion-folded polyethylene cover and (14 x 30cm) CIV-Fl
00841436103947	Sterile (15.2 tapered to 7.6 x 244cm) polyethylene accordion-folded cover with large nose cone f
00841436103930	Sterile (15.2 tapered to 7.6 x 244cm) polyethylene accordion-folded cover with Sterile (15.2 tap
00841436103701	Sterile (15.2 tapered to 7.6 x 244cm) accordion-folded polyethylene (14 x 30cm) CIV-Flex™ cove
00841436103619	Sterile (15.2 tapered to 7.6 x 244cm) flat-folded polyethylene cover and (14 x 30cm) CIV-Flex™