FDA.reportPublic FDA data

FMS NEXTRA

Primary DI
20886705000057
Brand
FMS NEXTRA
Company
DEPUY MITEK, LLC
Model
283305
Catalog number
283305
Device description
FMS neXtra 3.5mm Full Radius Cutter Shaver Blades
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXARTHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886705000057PackageGS15Not in Commercial Distribution
10886705000050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670500005720886705000057
1088670500005010886705000050

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, single-useA sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius49 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit120 Degrees Fahrenheit
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Pallet 2 Stacked
Storage Environment Temperature5 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
190572854
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705011049STRAIGHTSHOT2322152322152015-09-01
10886705011056STRAIGHTSHOT2322202322202015-09-01
10886705017836BRISTOW LATARJET2851802851802015-09-01
10886705022533BRISTOW LATARJET2851432851432015-09-01
10886705004980VERSALOK2154402154402015-09-01
10886705018178BRISTOW LATARJET2853452853452015-09-01
10886705025213EXPRESSEW2141592141592017-03-17
10886705007516FASTIN ETHIBOND2221522221522015-09-01
20886705000903NA2103092103092015-09-01
10886705000951NA2104092104092015-09-01
10886705001088LUPINE ETHIBOND2107102107102015-09-01
10886705001958QUICKANCHOR PANACRYL2121312121312015-09-01
10886705001989GII QUICKANCHOR PANACRYL2121342121342015-09-01
10886705001996QUICKANCHOR PANACRYL2121352121352015-09-01
10886705002047ETHIBOND2123102123102015-09-01
20886705002051ETHIBOND2123152123152015-09-01
10886705002061GII ETHIBOND2124502124502015-09-01
10886705002184PANALOK QUICKANCHOR PANACRYL2127322127322015-09-01
10886705002191PANALOK QUICKANCHOR ORTHOCORD2127332127332015-09-01
20886705002204GII PANACRYL2127342127342015-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854041116POWERPROConmed CorporationHRX2026-03-24
04056702011970PUREVUE™ FMSW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011987Autoclavable remote controlW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011994Double pedal foot switchW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012014Tube set for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012038Tube set for suction, 2-lines, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012113Tube set for suction, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012137Tube set inflow 4-Spike adaptorW.O.M. World of Medicine GmbHHRX2026-03-10
00763000956028Tubing SetMEDTRONIC XOMED, INC.HRX2026-02-14
B382SD401290Surgical DirectSurgical Direct, Inc.HRX2026-02-09
B382SD401490Surgical DirectSurgical Direct, Inc.HRX2026-02-09
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08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHRX2025-12-17
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08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHRX2025-12-17
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08800038029361SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
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08800038029415SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24