FDA.reportPublic FDA data

n.a.

Primary DI
04048551057261
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13992BS
Catalog number
13992BS
Device description
Water Bottle, 250 ml
Published
2024-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCTLight source, endoscope, xenon arc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCTLight Source, Endoscope, Xenon ArcGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551057261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551057261040485510572614048551057261

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration pump, reusableAn electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
true
Manufacturing 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
10845854080634CONMEDConmed CorporationGCT2026-03-24
10845854041291CONMEDConmed CorporationGCT2026-03-24
00840183528607BR Surgical, LLCBR Surgical, LLCGCT2024-10-24
00857556008468BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008475BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008543BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
10845854041307CONMEDConmed CorporationGCT2023-12-04
10845854041314CONMEDConmed CorporationGCT2023-12-04
04961333083701PENTAXHOYA CORPORATIONGCT2023-07-31
04250369707317ILOILO electronic GmbHGCT2023-06-22
04250369707324ILOILO electronic GmbHGCT2023-06-22
04250369707348ILOILO electronic GmbHGCT2023-06-22
04250369707355ILOILO electronic GmbHGCT2023-06-22
04250369707362ILOILO electronic GmbHGCT2023-06-22
04250369707379ILOILO electronic GmbHGCT2023-06-22
04250369707690ILOILO electronic GmbHGCT2023-06-22
04250369707706ILOILO electronic GmbHGCT2023-06-22
04250369707713ILOILO electronic GmbHGCT2023-06-22
04250369707720ILOILO electronic GmbHGCT2023-06-22
04250369707737ILOILO electronic GmbHGCT2023-06-22
04250369707744ILOILO electronic GmbHGCT2023-06-22
04953170400476XENON LUMPOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-18
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-17
04048551166116n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551325995n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346266n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346273n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346303n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551062838n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
00857580006669Light SourceGULF FIBEROPTICS, INC.GCT2017-12-01