FDA.reportPublic FDA data

n.a.

Primary DI
04048551075319
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27035L
Catalog number
27035L
Device description
Biopsy Forceps, 7 Fr., 40 cm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGCURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGCUrethroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945907000KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURESKARL STORZ Endoscopy-America, Inc.1995-05-12FGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551075319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551075319040485510753194048551075319

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

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
04048551390153n.a.Karl Storz GmbH & Co. KGFGC2018-08-17
04048551075333n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551073681n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075272n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
04048551075296n.a.Karl Storz GmbH & Co. KGFGC2016-09-23
00855308006021DirectVisionPERCUVISION LLCFGC2016-09-23
00855308006038DirectVisionPERCUVISION LLCFGC2016-09-23
04042761077491OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077507OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077545OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077569OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077576OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21
04042761077729OlympusOLYMPUS Winter & Ibe GmbHFGC2016-09-21