FDA.reportPublic FDA data

FMS

Primary DI
20886705016331
Brand
FMS
Company
DEPUY MITEK, LLC
Model
281580
Catalog number
281580
Device description
FMS Fluid Management System 4.5mm FMS Outflow Cannula
Published
2015-09-01
Public version status
Update
Distribution status
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
HNXDepressor, orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886705016331PackageGS120In Commercial Distribution
10886705016334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670501633120886705016331
1088670501633410886705016334

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. 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

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
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451339212INAMIINAMI & CO., LTD.HNX2026-01-29
04547451339045InamiINAMI & CO., LTD.HNX2025-12-05
04058935013394Depressor Scleral FlynnBausch & Lomb GmbHHNX2025-10-26
00757770483235Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770498765Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770500444Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770524914Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00194613011604MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613011628MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613109738MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
G412DP20600MR PHACOCrestpoint Management LimitedHNX2025-05-27
00194613119959MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-03-21
00757770406685Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770414703Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770425136Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770432097Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770435326Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00192896120273Schepens Scleral DepressorSONTEC INSTRUMENTS, INC.HNX2024-10-15
00757770426676Bausch + LombBausch & Lomb IncorporatedHNX2024-08-26
00887482049297Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNX2024-08-20
00194613087753MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087760MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087777MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087821MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00887482111475Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111482Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111499Symmetry FlynnASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCHNX2024-06-03
08175700156110Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
08175700156127Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06