FDA.reportPublic FDA data

n.a.

Primary DI
04048551080504
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27105B
Device description
Aspiration Insert Tube
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
ODBendoscopic contamination prevention sheath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODBEndoscopic Contamination Prevention SheathGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943697000TROCARS,CANNULAE,SHEATHS,OBTURATORSKarl Storz Endoskop GmbH1994-09-14ODB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551080504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551080504040485510805044048551080504

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic catheter introducer, reusableA rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel. 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
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
00860009064706Transport Endoscopic Access DeviceUsgi Medical, Inc.ODB2022-12-20
00860009064751Transport Endoscopic Access DeviceUsgi Medical, Inc.ODB2022-12-20
04048551231562n.a.Karl Storz GmbH & Co. KGODB2018-07-21
08714729974604ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974611ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974628ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974635ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974642ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
04048551016695n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074114n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074138n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074152n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074176n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074190n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074213n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074237n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074251n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074336n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074374n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074411n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074459n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074480n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074497n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074510n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074541n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074664n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074688n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074701n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074725n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074763n.a.Karl Storz GmbH & Co. KGODB2016-09-23