FDA.report

Tampa Catheter for Hysterosonography

Primary DI
20888937016394
Brand
Tampa Catheter for Hysterosonography
Company
Coopersurgical, Inc.
Model
61-2005
Device description
Tampa Catheter for Hysterosonography 5 French • 33 cm Long
Published
2017-10-04
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

Related Records

Product Codes

CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications

CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K970492000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K970492000INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERAckrad Laboratories1997-04-09LKF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888937016394PackageGS120In Commercial Distribution
00888937016390PrimaryGS10

GMDN Terms

TermDefinition
Salpingographic catheterA flexible, balloon-tipped tube inserted transvaginally and through the uterus for the selective catheterization/cannulation of the fallopian tubes, in order to inject dye or a contrast medium into the tubes for a radiographic procedure; it is usually radiopaque. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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