FDA.reportPublic FDA data

FMS

Primary DI
10886705017430
Brand
FMS
Company
DEPUY MITEK, LLC
Model
284510
Catalog number
284510
Device description
FMS Patient Set Without One-Way Valve Arthroscopy Tubing
Published
2017-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K951843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951843000REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KITFuture Medical Systems, Inc.1995-07-14HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886705017437PackageGS124In Commercial Distribution
10886705017430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670501743720886705017437
1088670501743010886705017430

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Pallet 2 Stacked
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
190572854
Device count
1
Lot or batch
true
Expiration date on label
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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00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
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