FDA.reportPublic FDA data

n.a.

Primary DI
04048438004692
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
031135-10
Device description
Adaptor for CADIERE handle 38112 C
Published
2019-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NVTTubing and tubing/filter fits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVTTubing And Tubing/Filter FitsObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048438004692PrimaryGS10
04048438004685Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048438004692040484380046924048438004692
04048438004685040484380046854048438004685

GMDN Terms#

Term, Definition table
TermDefinition
Pin-indexed adaptor, single-useA connecting device designed to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a single-use device.

Regulatory Flags#

DUNS number
315731430
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551161005n.a.408001102018-09-04
04048551291030NAV1408100202018-08-23
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327626469ThermaClearSTRYKER CORPORATIONNVT2025-04-04
05055270979636RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979667RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986504RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979643RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979674RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986511RocketROCKET MEDICAL PLCNVT2023-10-24
05708265011179LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011841LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011186LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011858LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
04048438003497n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438003619n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004401n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438001080n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000762n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000823n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438006306n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
05708265010585LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
05708265010592LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
00815849020191Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020207Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020214Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022461Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020764Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020771Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020788Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022478Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09