FDA.reportPublic FDA data

n.a.

Primary DI
04048551055007
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13250LN
Catalog number
13250LN
Device description
Biopsy Forceps, 2.3 mm, 200 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
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063585000KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.2007-01-31FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551055007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551055007040485510550074048551055007

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
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
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
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06973786293284Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293307Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293321Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15