FDA.reportPublic FDA data

KSlock

Primary DI
04048551265239
Brand
KSlock
Company
Karl Storz GmbH & Co. KG
Model
28272UGN
Catalog number
28272UGN
Device description
Clamping Jaw, big
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
OCVEndoscope holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCVEndoscope HolderGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951535000KARL STORZ ENDOSCOPES, TELESCOPE HOLDERSKARL STORZ Endoscopy-America, Inc.1995-05-09GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551265239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551265239040485512652394048551265239

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic multi-instrument access port, single-useA sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use 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
04260463842333ENDOSCOPE CLAMP AAktormed GmbHOCV2026-02-25
04260463845273STERILISATION TRAYAktormed GmbHOCV2026-02-25
04260463846867ENDOSCOPE CLAMP BAktormed GmbHOCV2026-02-25
04260463849066CONTROLAktormed GmbHOCV2026-02-25
04260463849127ENDOFIX EXO SETAktormed GmbHOCV2026-02-25
04260463849271CONE ADAPTERAktormed GmbHOCV2026-02-25
04260463849431Endofix EXOAktormed GmbHOCV2025-07-30
04048551255902POINT SETTERKarl Storz GmbH & Co. KGOCV2020-03-02
04048551422328n.a.Karl Storz GmbH & Co. KGOCV2020-03-02
04048551422335n.a.Karl Storz GmbH & Co. KGOCV2020-03-02
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMBIOMET MICROFIXATION, INCOCV2019-06-17
04048551410912n.a.Karl Storz GmbH & Co. KGOCV2019-02-23
04048551337400VERSACRANEKarl Storz GmbH & Co. KGOCV2018-08-21
04048551366967n.a.Karl Storz GmbH & Co. KGOCV2018-08-21
04048551313114n.a.Karl Storz GmbH & Co. KGOCV2018-08-17
04048551193655n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551195475n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551193679n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551251669n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551405109n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551107539n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551111031KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111048KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111055KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111383KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551111413KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551265222KSlockKarl Storz GmbH & Co. KGOCV2016-09-23
04048551321560VERSACRANEKarl Storz GmbH & Co. KGOCV2016-09-23
04048551322475n.a.Karl Storz GmbH & Co. KGOCV2016-09-23
04048551322482n.a.Karl Storz GmbH & Co. KGOCV2016-09-23