Home GUDID 20888937011290
Papette
Primary DI 20888937011290
Brand Papette
Company Coopersurgical, Inc.
Model 908003
Device description WALLACH Papette® (Non-Sterile) Cervical Cell Sampler
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HHT Spatula, Cervical, Cytological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HHT Spatula, Cervical, Cytological Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20888937011290 Package GS1 1000 In Commercial Distribution 50888937011291 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20888937011290 20888937011290 50888937011291 50888937011291
GMDN Terms# Term, Definition table Term Definition Uterine manipulator, single-use A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.
Regulatory Flags# DUNS number 801895244 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 false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860011506300 CytoSoft Medical Packaging Corporation HHT 2026-02-18 00860011506324 CytoSoft Medical Packaging Corporation HHT 2026-02-18 00860011506331 CYTO-PAK Medical Packaging Corporation HHT 2026-02-18 07898027908460 KOLPLAST Kolplast C I HHT 2023-11-29 08809157488011 C20310 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488028 C20310 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488035 C20310 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488042 C20310 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488110 C21150 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488127 C21150 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488134 C21150 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488141 C21150 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488219 C27024 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488226 C27024 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488233 C27024 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488240 C27024 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488318 C27632 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488325 C27632 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488332 C27632 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488349 C27632 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488417 C29000 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488424 C29000 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488431 C29000 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488448 C29000 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488516 C60100 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488523 C60100 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488530 C60100 B&B Company Co.,Ltd. HHT 2023-07-17 08809157488547 C60100 B&B Company Co.,Ltd. HHT 2023-07-17 18719189246084 Rovers® Cervex-Brush® Combi Rovers Medical Devices B.V. HHT 2023-07-12 18719189246213 Rovers® Viba-Brush® Rovers Medical Devices B.V. HHT 2023-07-12