FDA.reportPublic FDA data

MODUS

Primary DI
07630037850380
Brand
MODUS
Company
Medartis AG
Model
M-6710
Catalog number
M-6710
Device description
Holding Rack f. Implant and Instr. Cases
Published
2021-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202589000APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AG2020-11-06HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630037850380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630037850380076300378503807630037850380

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480054895
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630894827495AVENGERM70HC018M70HC0182026-10-21
07630894827501AVENGERM70HC020M70HC0202026-10-21
07630894827518AVENGERM70HC022M70HC0222026-10-21
07630894827525AVENGERM70HC024M70HC0242026-10-21
07630894827532AVENGERM70HC118M70HC1182026-10-21
07630894827549AVENGERM70HC120M70HC1202026-10-21
07630894827556AVENGERM70HC122M70HC1222026-10-21
07630894827563AVENGERM70HC124M70HC1242026-10-21
07630894827570AVENGERM70HC218M70HC2182026-10-21
07630894827587AVENGERM70HC220M70HC2202026-10-21
07630894827594AVENGERM70HC222M70HC2222026-10-21
07630894827600AVENGERM70HC224M70HC2242026-10-21
07630894827617AVENGERM70SC055M70SC0552026-10-21
07630894827624AVENGERM70SC065M70SC0652026-10-21
07630894827631AVENGERM70SC075M70SC0752026-10-21
07630894827648AVENGERM70SC085M70SC0852026-10-21
07630894827655AVENGERM70SC095M70SC0952026-10-21
07630894827662AVENGERM70SC155M70SC1552026-10-21
07630894827679AVENGERM70SC165M70SC1652026-10-21
07630894827686AVENGERM70SC175M70SC1752026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095297INSTRUSAFESummit Medical, Inc.KCT2026-10-22
00642356006215Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006222Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006239Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006246Storz Ophthalmic InstrumentsMastel Surgical Inc.KCT2026-10-22
00642356006253SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006260SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006277SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006284SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006291SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006345SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006352SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006369SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006376SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006383SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006390SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006406SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006413SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006420SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006437SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006444SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006451SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006468SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006475SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006482SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006499SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006505SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006512SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006529SteriBestMastel Surgical Inc.KCT2026-10-22
00642356006536SteriBestMastel Surgical Inc.KCT2026-10-22