FDA.reportPublic FDA data

Aesculap

Primary DI
04250325493759
Brand
Aesculap
Company
Vitalitec International Medizintechnik GmbH
Model
PE485A
Catalog number
PE485A
Device description
Aesculap Full-HD Arthroscope, 0°, 4,0mm
Published
2019-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942730000AESCULAP LAPAROSCOPESAesculap, Inc.1995-04-25HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250325493759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250325493759042503254937594250325493759

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328485453
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250325498877VitalitecVK.J805CVUQRVK.J805CVUQR2025-05-28
04250325499423VitalitecVMJ902QRVMJ902QR2025-05-28
04250325499430VitalitecVMJ903QRVMJ903QR2025-05-28
04250325499720VitalitecVK.J704CVUQRVK.J704CVUQR2025-05-28
04250325499737VitalitecVK.J705CVUQRVK.J705CVUQR2025-05-28
04250325499744VitalitecVK.J801CVUQRVK.J801CVUQR2025-05-28
04250325499751VitalitecVMJ1001QRSVMJ1001QRS2025-05-28
04250325499768VitalitecVMJ1002QRSVMJ1002QRS2025-05-28
04250325499775VitalitecVMJ1003QRSVMJ1003QRS2025-05-28
04250325499782VitalitecVMJ1004QRSVMJ1004QRS2025-05-28
04250325499799VitalitecVMJ1005QRSVMJ1005QRS2025-05-28
04250325499805VitalitecVMJ1005QRVMJ1005QR2025-05-28
04250325499812VitalitecVMJ1002QRBCVMJ1002QRBC2025-05-28
04250325499904VitalitecVMJ701QRVMJ701QR2025-05-28
04250325499911VitalitecVMJ702QRVMJ702QR2025-05-28
04250325499928VitalitecVMJ703QRVMJ703QR2025-05-28
04250325499935VitalitecVMJ704QRVMJ704QR2025-05-28
04250325499942VitalitecVMJ705QRVMJ705QR2025-05-28
04250325499959VitalitecVMJ901QRVMJ901QR2025-05-28
04250325499966VitalitecVMJ904QRVMJ904QR2025-05-28

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