FDA.reportPublic FDA data

NA

Primary DI
10886705026210
Brand
NA
Company
Medos International Sàrl
Model
242012
Catalog number
242012
Device description
HD Arthroscope: Compatible with Storz Style 4.0mm, 30 DEGREES, 175mm
Published
2016-01-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXARTHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971996000MEDIVISION ARTHROSCOPMedivision Scope Service Center, Inc.1997-07-31HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705026210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670502621010886705026210

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015986504Joint Preservation Innovations, LLCJoint Preservation Innovations, LLCHRX2026-11-05
00860015986511Joint Preservation Innovations, LLCJoint Preservation Innovations, LLCHRX2026-11-05
04048551432822ENDOMAT SELECTKarl Storz GmbH & Co. KGHRX2026-11-02
042503371190364K UHD Laminoscope (4.7 WCh), comboJoimax GmbHHRX2026-11-02
042503371190434K UHD Laminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
042503371191354K UHD Laminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
042503371191424K UHD Laminoscope (4.7 WCh), comboJoimax GmbHHRX2026-11-02
042503371191594K UHD Foraminoscope (4.7 WCh), comboJoimax GmbHHRX2026-11-02
042503371191664K UHD Foraminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
04250337120308Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120605Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120643Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLHRX2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLHRX2026-09-30
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011690Arthroscope Ø 2.7 mm, 30°, 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
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23