FDA.reportPublic FDA data

Brachytherapy Kit 3

Primary DI
00841436103053
Brand
Brachytherapy Kit 3
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-1295-5
Catalog number
610-1295-5
Device description
Sterile (81.3 x 91.4cm) polyethylene drape (2), non-sterile (2 x 14cm) endocavity balloon (2) for use with AccuCARE Positioning and Stabilizing equipment
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K970513000
K992152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970513000GENERAL PURPOSE TRANDUCER COVERCIVCO Medical Instruments Co., Inc.1997-06-20ITX
K992152000GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFFCIVCO Medical Instruments Co., Inc.1999-08-17ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436103053PrimaryGS10
80841436103059Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436103053008414361030538414361030530841436103053
8084143610305980841436103059

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, image-enhancementA non-sterile sheath containing an extraluminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch
Lumen/Inner Diameter0.83Inch

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

Contacts#

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

Regulatory Flags#

DUNS number
134614411
Device count
2
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22
00841436108317TEE Kit811-051811-0512017-08-22
00841436108324TEE Kit811-052811-0522017-08-22
00841436108331TEE Kit811-053811-0532017-08-22
00841436108348TEE Kit811-054811-0542017-08-22
00841436108355TEE Kit811-055811-0552017-08-22
00841436108362TEE Kit811-056811-0562017-08-22
00841436108379TEE Kit811-057811-0572017-08-22
00841436111133Laparostat810-212810-2122017-08-22
10841436122655Needle Guide667-187667-1872025-12-31
10841436126240Needle Guide610-1557610-15572025-12-31
10841436126257Needle Guide610-1558610-15582025-12-31
00841436122894Verza Guidance System639-064639-0642025-12-31
00841436125345Verza Guidance System667-196667-1962025-12-31
00841436125802Verza Guidance SystemH48062APH48062AP2025-12-31
00841436125826Needle Guidance SystemH48062ARH48062AR2025-12-31
00841436125840Needle Guidance SystemH48062ASH48062AS2025-12-31

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