FDA.reportPublic FDA data

PIPELLE® MARK II

Primary DI
03700111425705
Brand
PIPELLE® MARK II
Company
LABORATOIRE CCD
Model
PIPELLE® MARK II
Catalog number
111020100
Device description
Device for endometrial sampling
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
HHKCURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHKCurette, Suction, Endometrial (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700111425705PackageGS125In Commercial Distribution
03700111400702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700111425705037001114257053700111425705
03700111400702037001114007023700111400702

GMDN Terms#

Term, Definition table
TermDefinition
Cervical cytology brushA device with bristle-like projections designed to obtain a cervical biopsy of a suspicious area or visible exocervical lesions detected during a vaginal examination for the purpose of obtaining a tissue diagnosis from a woman with intraepithelial disease. It is inserted into the vagina and the head of the brush is firmly rotated over the area of interest until is covered with a bloody-mucoid sample. Some types may also have small bristles on a central protrusion that simultaneously enters the endocervical canal. The sample is secured in a cytology fixation solution or smeared onto a microscope slide for a Papanicolaou test (PAP). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length23.5Centimeter
Outer Diameter0.31Centimeter

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)344266377Infomed@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
00860011927662Monarch Medical ProductsBioteque Taiwan Ltd.HHK2026-07-24
04719894436487LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436494LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436500LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
06974500612718Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612725Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612732Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612749Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612756Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612763Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612770Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612787Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612794Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612824Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612831Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612848Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612855Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612862Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612879Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612886Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612893Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612909Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613333Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613340Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613357Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613364Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613371Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
00810142352338Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
00810142352369Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
04719894432335BiotequeBioteque Taiwan Ltd.HHK2024-12-06