Home GUDID 00841494104672 SPECULUM
Primary DI 00841494104672
Brand SPECULUM
Company Cynosure, LLC
Model H57
Catalog number H57
Device description "SPECULUM - STANDARD 4-1/2"" LENGTH"
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HDF SPECULUM, VAGINAL, METAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HDF Speculum, Vaginal, Metal Obstetrics/Gynecology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841494104672 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841494104672 00841494104672 841494104672 0841494104672
GMDN Terms# Term, Definition table Term Definition Vaginal speculum, reusable A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.
Regulatory Flags# DUNS number 780318028 Device count 1 DM exempt true Premarket exempt true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841494100025 Focus Cap Array 100-7012-055 2016-09-24 00841494100001 PicoSure 100-7012-010 2016-09-24 00841494100056 Elite MPX 100-7009-010 2016-09-24 00841494100063 Elite+ 100-7018-010 2016-09-24 00841494100070 Apogee+ 100-7018-290 2016-09-24 00841494100100 Accolade 100-7008-010 2016-09-24 00841494100551 Spacer tip, handpiece 130-7012-324 2016-09-24 00841494100568 Spacer tip for 532 Handpiece 130-7012-490 2016-09-24 00841494103354 532 Lite Handpiece 659-0644 2016-09-24 00841494103583 PicoSure 1064 nm Handpiece 100-7012-079 2016-09-24 00841494103590 PicoSure 532 nm Handpiece 100-7012-076 2016-09-24 00841494103675 Elite+ / Elite MPX Treatment Tip 100-7018-100 2016-09-24 00841494106775 SculpSure, Laser Assembly, Brazil 100-7026-020 2017-07-24 00841494106980 PicoSure 532 Delivery System 100-7012-532 2017-07-24 00841494106997 PicoSure 1064 Delivery System 100-7012-164 2017-07-24 00841494107246 Refusrbished, Handpiece, 1064, Pico R100-7012-079 2017-07-24 00841494107253 Refusrbished, Handpiece, 532, Pico R100-7012-076 2017-07-24 00841494104214 PERF-GRID EPG107 EPG107 2016-09-21 00841494104689 SPLINT GRID NYLON MESH ROLL ESG118 ESG118 2016-09-21 00841494104696 SPLINT MESH STAINLESS STEEL MESH ROLL ESG117 ESG117 2016-09-21
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