FDA.reportPublic FDA data

STERILISATION TRAY

Primary DI
04260463845273
Brand
STERILISATION TRAY
Company
Aktormed GmbH
Model
141527
Device description
Sterilisation tray with small parts tray for sterilisable parts of ENDOFIX exo
Published
2026-02-25
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
OCVEndoscope Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCVEndoscope HolderGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232405000ENDOFIX EXOAktormed GmbH2024-04-25OCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260463845273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463845273042604638452734260463845273

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537223815
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260463842333ENDOSCOPE CLAMP A1822332026-02-25
04260463846867ENDOSCOPE CLAMP B1516862026-02-25
04260463849066CONTROL1719062026-02-25
04260463849127ENDOFIX EXO SET1719122026-02-25
04260463849271CONE ADAPTER1719272026-02-25
04260463849431Endofix EXO1719432025-07-30
04260463845181PROBE PIN2125182125182024-10-02
04260463842821STERILISATION TRAY XL1922821922822024-10-01
04260463844801CANTILEVER2124802124802024-10-01
04260463844825JOINT2124822124822024-10-01
04260463844993Dexter Endoscope Arm2124992124992024-10-01
04260463845907ENDOSCOPE CLAMP2225902225902024-10-01
04260463844276Joystick RH - IIA2024272022-04-12
04260463845433Joystick LH-US2125432022-04-12
04260463845440Joystick RH-US2125442022-04-12
04260463840919JOYSTICK-LH1720912021-04-29
04260463840650MOUNT-1B1720652021-04-29
04260463840667MOUNT-1A1720662021-04-29
04260463840674MOUNT-2A1720672021-04-29
04260463840681MOUNT-2B1720682021-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260463842333ENDOSCOPE CLAMP AAktormed 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
04048551265239KSlockKarl 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