FDA.reportPublic FDA data

n.a.

Primary DI
04048551410912
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
28272AR
Device description
Armrest
Published
2019-02-23
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
OCVEndoscope holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCVEndoscope HolderGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990334000KSEA ENDOSCOPE HOLDERKARL STORZ Endoscopy-America, Inc.1999-03-22OCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551410912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551410912040485514109124048551410912

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. 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
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
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