FDA.reportPublic FDA data

n.a.

Primary DI
04048438005170
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
041150-20
Catalog number
041150-20
Device description
Cover, with elastic tip
Published
2018-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMWDrape, microscope, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMWDrape, Microscope, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048438005170PrimaryGS10
04048438005163Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048438005170040484380051704048438005170
04048438005163040484380051634048438005163

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

Regulatory Flags#

DUNS number
315731430
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810123208616Adler Instrument CompanyAdler, Inc.HMW2025-02-18
00810123208135Adler Instrument CompanyAdler, Inc.HMW2024-12-13
00840277124739Innomed, Inc.INNOMED, INC.HMW2020-01-31
00027479193194SpandaGripMEDI-TECH INTERNATIONAL CORPORATIONHMW2019-07-01
00852205007892Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007922Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007915Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007946Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
10885403067532V. MuellerCAREFUSION 2200, INCHMW2017-10-17
10885403133893V. MuellerCAREFUSION 2200, INCHMW2017-10-17
10885403067600V. MuellerCAREFUSION 2200, INCHMW2017-10-17
20885403067539V. MuellerCAREFUSION 2200, INCHMW2017-10-17
20885403133890V. MuellerCAREFUSION 2200, INCHMW2017-10-17
00190769003555Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLCHMW2017-07-17
10190769003552Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLCHMW2017-07-17
04049539103536Sterilizable Metal SleeveCarl Zeiss Meditec AGHMW2017-05-04
040495391024542-Pack Asepsis VISULUXCarl Zeiss Meditec AGHMW2017-05-04
04049539103284Sterilizable Metal SleeveCarl Zeiss Meditec AGHMW2017-05-04
00815384021004OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021035OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021066OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021097OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021127OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021158OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021189OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021240OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021271OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021301OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021332OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021363OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24