CIV-Clear™ Transducer Cover 610-2366

GUDID 00841436120319

Sterile (14x244cm) telescopically-folded cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

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Primary Device ID	00841436120319
NIH Device Record Key	673c14e1-0f07-4201-b807-026df406f36c
Commercial Distribution Status	In Commercial Distribution
Brand Name	CIV-Clear™ Transducer Cover
Version Model Number	610-2366
Catalog Number	610-2366
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	true
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
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

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120319 [Package] Contains: 10841436120316 Package: [24 Units] In Commercial Distribution
GS1	00841436122962 [Package] Package: [5 Units] In Commercial Distribution
GS1	10841436120316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211270

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

[00841436120319]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-11-29
Device Publish Date	2021-11-20

On-Brand Devices [CIV-Clear™ Transducer Cover]

00841436120326	Sterile (10.2x122cm) telescopically-folded cover (no gel)
00841436120319	Sterile (14x244cm) telescopically-folded cover
00841436120302	Sterile (10.2x122cm) telescopically-folded cover
00841436120296	Sterile (8.9x91.5cm) telescopically-folded cover
00841436120289	Sterile (14x122cm) telescopically-folded cover
00841436120272	Sterile (14x91.5cm) telescopically-folded cover
00841436120265	Sterile (14x61cm) flat-folded cover
80841436121244	Non-sterile (14x61cm) flat-folded cover