FDA.report

HSG Tray

Primary DI
20888937003264
Brand
HSG Tray
Company
Coopersurgical, Inc.
Model
6050T
Device description
For hysterosalpingography procedures
Published
2016-07-29
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
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications

CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K920803000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K920803000HSG TRAYUnimar, Inc.1992-10-19HIB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888937003264PackageGS112In Commercial Distribution
60888937003262PrimaryGS10

GMDN Terms

TermDefinition
Fallopian tube catheterization kitA collection of sterile devices designed for the transuterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency during salpingoscopy/fluoroscopy, ultrasonography, hysteroscopy, or laparoscopy. It typically consists of a dedicated catheter with a balloon, a syringe to inflate the balloon, a secondary catheter [e.g., a tungsten (W) tipped catheter], a guidewire, and connectors. Some types may also facilitate the entry of other devices/instruments for procedures within the fallopian tubes. 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
true
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
false
Sterilization required before use
false

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00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
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