FDA.reportPublic FDA data

Olympus

Primary DI
04042761006897
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
A4826
Catalog number
A4826
Published
2023-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWWAccessory - Film Dosimetry System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWWAccessory - Film Dosimetry SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761006897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761006897040427610068974042761006897

GMDN Terms#

Term, Definition table
TermDefinition
Gynaecological scissors, reusableA hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
316957240
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9876X00Radiochromic.comRADIOCHROMIC SL.MWW2025-12-09
00810106410845FilmQA ProASHLAND SPECIALTY INGREDIENTS G.P.MWW2025-02-12
B9875X10Radiochromic.comRADIOCHROMIC SL.MWW2024-06-10
B9875X00Radiochromic.comRADIOCHROMIC SL.MWW2023-12-10
00866562000274Standard Imaging RAy SoftwareSTANDARD IMAGING INC.MWW2023-06-22
B9874X00Radiochromic.comRADIOCHROMIC SL.MWW2022-04-08
00850000065000FilmQA ProASHLAND SPECIALTY INGREDIENTS G.P.MWW2021-09-23
B9873X40Radiochromic.comRADIOCHROMIC SL.MWW2021-09-11
B9873X30Radiochromic.comRADIOCHROMIC SL.MWW2020-10-21
00866498000300RayAGILE RADIOLOGICAL TECHNOLOGIESMWW2017-10-02
EIBAE60200100MatriXX PT kalibriertIBA Dosimetry GmbHMWW2016-09-09
EIBAM10136410DigiPhant IBA Dosimetry GmbHMWW2016-09-09