FDA.reportPublic FDA data

Surgi-Tip Transducer Cover

Primary DI
10841436110348
Brand
Surgi-Tip Transducer Cover
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
UA0072
Catalog number
UA0072
Device description
Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (9cm) NeoGuard™ tip for use with BK Medical 6C2, 8660, 8665, 8801, 8820e and 8830 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
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
00841436110341PackageGS112In Commercial Distribution
10841436110348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436110341008414361103418414361103410841436110341
1084143611034810841436110348

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
Length96Inch
Width8Inch

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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10841436103289eTRAX™ Needle610-1413-10610-1413-102017-08-29
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10841436103395eTRAX™ Needle610-1613-10610-1613-102017-08-29
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Primary DI, Brand, Company table
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