FDA.reportPublic FDA data

SPIRETTE®

Primary DI
03700111425736
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
Rx
false
OTC
false
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contains a rigid inner tube with a plunger that is positioned near the distal end; once in situ, the plunger is slowly withdrawn, creating a suction that draws mucous into the tube.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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
381633924
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
03700111400733SPIRETTE®LABORATOIRE 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
03700111425743MUCAT® STERILELABORATOIRE CCDHDR2023-12-05
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