FDA.report

n.a.

Primary DI
04048551375341
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
40820600
Device description
Holding Arm EM Navigation
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551375341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551375341040485513753414048551375341

GMDN Terms

TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000738358AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738365AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738372AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
04260759930003Integrated HeadrestFiagon GmbHPGW2025-06-25
04260759930119RegistrationPointerFiagon GmbHPGW2024-09-02
04260759930126VirtuEyeFiagon GmbHPGW2024-09-02
04260759930362PointerShell 4 mm Fiagon GmbHPGW2024-09-02
04260759930379PointerShell 5 mm Fiagon GmbHPGW2024-09-02
04260759930386PointerShell 3 mm Fiagon GmbHPGW2024-09-02
04260759930393PointerShell UniversalFiagon GmbHPGW2024-09-02
14260759930512Adhesive PadFiagon GmbHPGW2024-09-02
00763000768744StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769017StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769123StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769208StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000852818StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-26
04056481144685Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mmBrainlab AGPGW2023-05-05
04056481144692Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation ScrewBrainlab AGPGW2023-05-05
07613327513950ScopisStryker Leibinger GmbH & Co. KGPGW2022-10-20
07613327513943ScopisStryker Leibinger GmbH & Co. KGPGW2022-10-19
07613327514179ScopisStryker Leibinger GmbH & Co. KGPGW2022-10-19
20705031469218TruDi Shaver BladeACCLARENT, INC.PGW2022-09-09
20705031469232TruDi Shaver BladeACCLARENT, INC.PGW2022-09-09
20705031469270TruDi Shaver BladeACCLARENT, INC.PGW2022-09-09
20705031469294TruDi Shaver BladeACCLARENT, INC.PGW2022-09-09
00763000531539SteathStationMEDTRONIC NAVIGATION, INC.PGW2022-01-29
00763000531836SteathStationMEDTRONIC NAVIGATION, INC.PGW2022-01-29
00763000532109SteathStationMEDTRONIC NAVIGATION, INC.PGW2022-01-29