FDA.reportPublic FDA data

MIP Minimal Invasive PCNL

Primary DI
04048551367063
Brand
MIP Minimal Invasive PCNL
Company
Karl Storz GmbH & Co. KG
Model
27830BK
Device description
Operating Sheath for Children
Published
2018-07-21
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
FGAKit, nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551367063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551367063040485513670634048551367063

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
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
06925816667213ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657689ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657696ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657702ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657719ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657726ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657733ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657740ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
04055207038666NARichard Wolf GmbHFGA2024-04-01