FDA.reportPublic FDA data

SPIRETTE®

Primary DI
03700111400733
Brand
SPIRETTE®
Company
LABORATOIRE CCD
Model
SPIRETTE®
Catalog number
1106000
Device description
Device for cervical mucus aspiration
Published
2023-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDRCAP, CERVICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDRCap, CervicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700111425736PackageGS125In Commercial Distribution
03700111400733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700111425736037001114257363700111425736
03700111400733037001114007333700111400733

GMDN Terms#

Term, Definition table
TermDefinition
Cervical aspiration catheterA semi-rigid, sterile, tube designed to aspirate cervical mucous, typically for the evaluation of infertility. It is used to obtain cervical mucous samples for post-coital determination of spermatic hostility; it may also be used to remove a viscous mucous barrier prior to intrauterine insemination, embryo transfer, or other transcervical procedures. The tube usually contains a rigid inner tube with a plunger that is positioned near the distal end; once in situ, the plunger is slowly withdrawn, creating a suction that draws mucous into the tube. The mucous is typically expelled onto a microscope slide for examination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length26.4Centimeter
Outer Diameter0.26Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00-The product must not be used in the event of damaged, or open primary packaging before the medical procedure.-Store away from direct sunlight.-Store in a dry place.

Contacts#

Phone, Email table
PhoneEmail
+33(0)344266378Infomed@ccdlab.com

Regulatory Flags#

DUNS number
381633924
Device count
1
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
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
03700111401129RIGISTER CUPULE 35 mmRIGISTER CUPULE 35 mm2025-11-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065015660002Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
05065015660064Béa FertilitySTEPONE FERTILITY LTDHDR2025-07-24
00810028774124Frida FertilityFridababy, LLCHDR2023-12-05
03700111400542SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400559STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400566INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111400573MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111400740MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
10810028774121Frida FertilityFridababy, LLCHDR2023-12-05
03700111425545SMALL GENITOR® INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425552STANDARD INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425569INTRA UTERINE INSEMINATION CANNULA WITH MANDRELLABORATOIRE CCDHDR2023-12-05
03700111425576MEMORY INTRA UTERINE INSIMINATION CANNULALABORATOIRE CCDHDR2023-12-05
03700111425736SPIRETTE®LABORATOIRE CCDHDR2023-12-05
03700111425743MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
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