AccessGUDID - DEVICE: PIPELLE® (03700111400719)

GUDID

Device Identifier (DI) Information

Brand Name: PIPELLE®
Version or Model: PIPELLE®
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1103000
Company Name: LABORATOIRE CCD

Primary DI Number: 03700111400719
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381633924 *Terms of Use

Device Description: Device for endometrial sampling

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32368	Cervical cytology brush	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHK	CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: -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.

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 23.5 Centimeter
Outer Diameter: 0.31 Centimeter

Device Record Status

Public Device Record Key: ba1bbd58-1334-4937-b96d-037c5f27b9ac
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
03700111425712	25	03700111400719		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +33(0)344266376
Email: Infomed@ccdlab.com

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