FDA.reportPublic FDA data

Surgi-Tip Transducer Cover

Primary DI
00841436110365
Brand
Surgi-Tip Transducer Cover
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
UA0074
Catalog number
UA0074
Device description
Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard™ tip for use with BK Medical 10L2w, 13L4w, 14L3, 18L5, 8670, 8811, 8812, 8814, 8822 and 8870 transducers
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013721000SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVERCIVCO Medical Instruments Co., Inc.2001-12-28ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436110365PackageGS112In Commercial Distribution
10841436110362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436110365008414361103658414361103650841436110365
1084143611036210841436110362

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative ultrasound imaging transducer coverA sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length244Centimeter
Width20.3Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(319)248-6502regulatory@civco.com

Regulatory Flags#

DUNS number
134614411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
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00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
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10841436102435eTRAX™ Needle610-1213-10610-1213-102017-08-29
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10841436102640omniTRAX Patient Tracker610-1228610-12282017-08-22
10841436103128omniTRAX Active Patient Tracker610-1306610-13062017-08-22
10841436103289eTRAX™ Needle610-1413-10610-1413-102017-08-29
10841436103302eTRAX™ Needle610-1417-10610-1417-102017-08-29
10841436103395eTRAX™ Needle610-1613-10610-1613-102017-08-29
10841436103418eTRAX™ Needle610-1615-10610-1615-102017-08-29
10841436103531eTRAX™ Needle610-1815-10610-1815-102017-08-29
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
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