FDA.reportPublic FDA data

Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavable

Primary DI
04066524011690
Brand
Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavable
Company
XION GmbH
Model
125 303 103US
Catalog number
125 303 103US
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080560000HENKE SASS WOLF OF AMERICA ARTHROSCOPEHenke Sass Wolf of America, Inc.2008-03-18HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04066524011690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066524011690040665240116904066524011690

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity00
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
331589812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavable125 303 100US125 303 100US2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavable125 303 107US125 303 107US2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavable125 304 100UUS125 304 100UUS2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavable125 304 103UUS125 304 103UUS2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavable125 304 104UUS125 304 104UUS2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavable125 304 107UUS125 304 107UUS2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
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00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
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00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
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