Surgi-Tip Transducer Cover UA0073

GUDID 00841436110358

Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™ tip for use with BK Medical 8663, 8815, 8816, 8824, 8862, 8863 and N13C5 transducers

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

Primary Device ID	00841436110358
NIH Device Record Key	265b7a42-e9c8-4b2f-8417-5a62dd857897
Commercial Distribution Status	In Commercial Distribution
Brand Name	Surgi-Tip Transducer Cover
Version Model Number	UA0073
Catalog Number	UA0073
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

Device Dimensions

Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter
Length	244 Centimeter
Width	15.2 Centimeter

Operating and Storage Conditions

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	00841436110358 [Package] Contains: 10841436110355 Package: [12 Units] In Commercial Distribution
GS1	10841436110355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K013721

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

[00841436110358]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-09-06
Device Publish Date	2017-08-22

On-Brand Devices [Surgi-Tip Transducer Cover]

00841436110365	Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™
00841436110358	Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™
00841436110341	Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (9cm) NeoGuard™
00841436104180	Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™
00841436104173	Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached (3cm) NeoGuard™
00841436101929	Sterile (15.2 x 244cm) polyethylene accordion-folded cover with attached (3cm) NeoGuard™ Tip