FDA.reportPublic FDA data

FMS SOLO

Primary DI
10886705020614
Brand
FMS SOLO
Company
DEPUY MITEK, LLC
Model
284590
Catalog number
284590
Device description
FMS SOLO Irrigation System
Published
2015-09-01
Public version status
Update
Distribution status
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
K002040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002040000FMS SOLOFuture Medical Systems, Inc.2000-09-11HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705020614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670502061410886705020614

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Waste from Electrical and Electronic Equipment

Contacts#

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

Regulatory Flags#

DUNS number
190572854
Device count
1
Serial number
true

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
10886705002528QUICKANCHOR ETHIBOND TAPERCUT2128652128652015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705008223FASTIN ETHIBOND2227202227202015-09-01
10886705017454FMS2845492845492017-03-17
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023462HEALIX ADVANCE2223302223302015-09-01
10886705023479HEALIX ADVANCE2223312223312015-09-01
10886705023493HEALIX ADVANCE2223322223322015-09-01
10886705010684MILAGRO2318002318002015-09-01
10886705010738MILAGRO2318052318052015-09-01
10886705010776MILAGRO2318102318102015-09-01
10886705010783MILAGRO2318152318152015-09-01

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