Home GUDID 10649111068010 Sklar®
Primary DI 10649111068010
Brand Sklar®
Company SKLAR CORPORATION
Model 90-5291
Published 2016-10-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name HHW PESSARY, VAGINAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HHW Pessary, Vaginal Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10649111068010 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10649111068010 10649111068010
GMDN Terms# Term, Definition table Term Definition Pelvic-organ-supporting pessary A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.
Regulatory Flags# DUNS number 006966006 Device count 1 Premarket exempt true Lot or batch true Serial number true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09903124199524 CNTRL+ Bladder Support Pessary Cntrl+ Inc. HHW 2026-02-22 15019315015236 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015243 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015250 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015267 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015274 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015281 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015298 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015304 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015311 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015328 Wallace ICU MEDICAL, INC. HHW 2016-10-05 15019315015335 Wallace ICU MEDICAL, INC. HHW 2016-10-05 10381780169963 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780169970 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780169987 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780169994 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170006 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170013 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170020 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170037 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170044 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170051 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170068 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170075 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170082 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170099 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170105 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170112 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170129 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26 10381780170136 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HHW 2016-08-26