FDA.reportPublic FDA data

RIGISTER CUPULE 35 mm

Primary DI
03700111401129
Brand
RIGISTER CUPULE 35 mm
Company
LABORATOIRE CCD
Model
RIGISTER CUPULE 35 mm
Device description
Device for hysterosalpingography and chromopertubation
Published
2025-11-27
Public version status
New
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
HIGInsufflator, Hysteroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894259000REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULAWashington Regulatory Services1990-03-05HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700111401129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700111401129037001114011293700111401129

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine imaging medium catheterization kitA collection of sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It includes an intrauterine imaging medium catheter, devices dedicated to catheter function (e.g., stylet, syringe), and non-dedicated supportive devices (e.g., drape, cervical dialator, gauze pad, swab sticks). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
381633924
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700111400801HOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cmHOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cm13010002023-12-05
03700111400818HOC CLASSIC WITHOUT VALVE Aspiration tube 67 cmHOC CLASSIC WITHOUT VALVE Aspiration tube 67 cm13010012023-12-05
03700111400825HOC2 CLASSIC WITHOUT VALVE SOFT PLUGHOC2 CLASSIC WITHOUT VALVE SOFT PLUG13010022023-12-05
03700111400863HOC COLLECTION VIAL 30MLHOC COLLECTION VIAL 30ML13020012023-12-05
03700111400931HOC A.R.T. OF C.C.D.® WITHOUT VALVEHOC A.R.T. OF C.C.D.® WITHOUT VALVE13133012023-12-05
03700111400948HOC A.R.T. OF C.C.D.® WITH VALVEHOC A.R.T. OF C.C.D.® WITH VALVE13134012023-12-05
03700111400955HOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUGHOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUG13135012023-12-05
03700111400962HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUGHOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUG13136012023-12-05
03700111401099RIGISTER CUPULE 20 mmRIGISTER CUPULE 20 mm14010202025-11-27
03700111401105RIGISTER CUPULE 25 mmRIGISTER CUPULE 25 mm14010252025-11-27
03700111401112RIGISTER CUPULE 30 mmRIGISTER CUPULE 30 mm14010302025-11-27
03700111401136SLIDING RIGISTER CUPULE 20 mmSLIDING RIGISTER CUPULE 20 mm14040202025-11-27
03700111401143SLIDING RIGISTER CUPULE 25 mmSLIDING RIGISTER CUPULE 25 mm14040252025-11-27
03700111401150SLIDING RIGISTER CUPULE 30 mmSLIDING RIGISTER CUPULE 30 mm14040302025-11-27
03700111401167SLIDING RIGISTER CUPULE 35 mmSLIDING RIGISTER CUPULE 35 mm14040352025-11-27
03700111400023FRYDMAN® CLASSIC 4.5FRYDMAN® CLASSIC 4.513060452023-12-05
03700111400030FRYDMAN® CLASSIC 5.5FRYDMAN® CLASSIC 5.513060552023-12-05
03700111400047FRYDMAN ® SOFT WITH GUIDEFRYDMAN ® SOFT WITH GUIDE13070002023-12-05
03700111400061T.D.T.®SETT.D.T.®SET13080002023-12-05
03700111400085INVENTCATH ECOINVENTCATH ECO13201212023-12-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700111401099RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401105RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401112RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401136SLIDING RIGISTER CUPULE 20 mmLABORATOIRE CCDHIG2025-11-27
03700111401143SLIDING RIGISTER CUPULE 25 mmLABORATOIRE CCDHIG2025-11-27
03700111401150SLIDING RIGISTER CUPULE 30 mmLABORATOIRE CCDHIG2025-11-27
03700111401167SLIDING RIGISTER CUPULE 35 mmLABORATOIRE CCDHIG2025-11-27
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00821925002630Gyrus ACMIGyrus ACMI, LLCHIG2024-12-09
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15420045516212Fluent Pro Fluid Management SystemHologic, Inc.HIG2024-08-06
04056702012861GYN-PumpW.O.M. World of Medicine GmbHHIG2024-06-28
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