FDA.reportPublic FDA data

MIP Minimal Invasive PCNL

Primary DI
04048551348710
Brand
MIP Minimal Invasive PCNL
Company
Karl Storz GmbH & Co. KG
Model
27830BBS
Device description
Operating Sheath for Supine Position
Published
2016-09-23
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
CodeName
FBQTrocar, gastro-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551348710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551348710040485513487104048551348710

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
true
Sterilization required before use
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
00849233015906Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2026-05-27
00849233014121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
10849233014128Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
00849233014015Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
10849233014012Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
00849233013162Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-05-01
00849233013124Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
10849233013121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
00849233012837Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
10849233012834Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
00849233012813Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
10849233012810Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
00849233012776Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
10849233012773Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
00849233012769Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
10849233012766Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
00849233012493Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
00849233012516Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012490Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012513Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
08964003163853Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163860Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163877Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163884Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163891Doctor NiceB. Ali ImpexFBQ2024-01-29
00849233011144Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-20
00849233011175Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
00849233011229Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011172Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011226Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16