FDA.reportPublic FDA data

HSG Tray

Primary DI
60888937003262
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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920803000HSG TRAYUnimar, Inc.1992-10-19HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937003264PackageGS112In Commercial Distribution
60888937003262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088893700326420888937003264
6088893700326260888937003262

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
801895244
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29
10860008900347ClearSpecClearspec LLCHIB2025-10-29
10860008900354ClearSpecClearspec LLCHIB2025-10-29
00860008900302ClearSpecClearspec LLCHIB2025-10-29
00860008900319ClearSpecClearspec LLCHIB2025-10-29
00860008900326ClearSpecClearspec LLCHIB2025-10-29
00860008900333ClearSpecClearspec LLCHIB2025-10-29
00860008900340ClearSpecClearspec LLCHIB2025-10-29
00860008900357ClearSpecClearspec LLCHIB2025-10-29
00199536930001BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930018BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930025BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930032BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930049BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930056BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
05010058091450UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091474UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091498UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091535UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091573UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091429UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-05-21
06972903330024SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
06972903330031SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11