FDA.reportPublic FDA data

Stahl

Primary DI
G592A196930HD0
Brand
Stahl
Company
S.H. Medical Corporation
Model
A1969.30HD
Device description
Arthroscope HD + 4K; D = 1.9mm, l = 69mm, 30 degree, wide angle, autoclavable
Published
2024-02-23
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031972000ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,Asap Endoscopic Products GmbH2003-09-15HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G592A196930HD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical 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 through relayed lens optics or a fibreoptic bundle. This device is typically 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
809139181
Device count
1
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G5921002030HD0Stahl10020.30HD 2024-02-23
G5921002930HD0Stahl10029.30HD2024-02-23
G5922000430HD0Stahl20004.30HD 2024-02-23
G592950500HD0Stahl9505.00HD2024-02-23
G592950530HD0Stahl9505.30HD2024-02-23
G592951000HD0Stahl9510.00HD 2024-02-23
G592951030HD0Stahl9510.30HD2024-02-23
G592A4017500HD01StahlA40175.00HD2024-02-23
G592A4017530HD0StahlA40175.30HD2024-02-23
G592A4017570HD0StahlA40175.70HD2024-02-23

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Primary DI, Brand, Company table
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