ecoFIX EPAV245CLA

GUDID 03760304680595

Ø 4.5 mm anchor mounted on reel with 2 round sutures

S.B.M

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable
Primary Device ID03760304680595
NIH Device Record Keyc2782ddb-30ac-4cf7-a41f-9951909b262c
Commercial Distribution StatusIn Commercial Distribution
Brand NameecoFIX
Version Model NumberecoFIX® Ø 4.5 mm Threaded Double-Loaded Suture Anc
Catalog NumberEPAV245CLA
Company DUNS772462123
Company NameS.B.M
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760304680595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-30
Device Publish Date2023-08-22

On-Brand Devices [ecoFIX]

03760304680595Ø 4.5 mm anchor mounted on reel with 2 round sutures
03760304680618Ø 6.5 mm anchor mounted on reel with 2 round sutures
03760304680601Ø 5.5 mm anchor mounted on reel with 2 round sutures
03760304681127Screwdriver to be used with diameter 5.5 mm and 6.5 mm ecoFIX anchors for rotator cuff repair.
03760304681110Screwdriver to be used with diameter 4.5 mm ecoFIX anchors for rotator cuff repair.
03760304681288Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
03760304681271Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
03760304681264Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
03760304681257Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a

Trademark Results [ecoFIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ECOFIX
ECOFIX
86714618 not registered Dead/Abandoned
United States Gypsum Company
2015-08-04
ECOFIX
ECOFIX
86009596 not registered Dead/Abandoned
Trydel Research Pty Ltd
2013-07-13
ECOFIX
ECOFIX
79105072 not registered Dead/Abandoned
Expo Display Service AG
2011-06-20
ECOFIX
ECOFIX
77390795 not registered Dead/Abandoned
Premier Tech Ltd.
2008-02-07
ECOFIX
ECOFIX
77149831 not registered Dead/Abandoned
Premier Tech Ltd.
2007-04-05
ECOFIX
ECOFIX
76287746 2637207 Live/Registered
MARS FISHCARE NORTH AMERICA, INC.
2001-07-19
ECOFIX
ECOFIX
75702072 2523928 Dead/Cancelled
Anton Hummel Verwaltungs GmbH
1999-05-10
ECOFIX
ECOFIX
75101135 2189703 Live/Registered
ALTRO USA, INC.
1996-05-09
ECOFIX
ECOFIX
74539372 1965974 Live/Registered
MERIDIAN BIOSCIENCE, INC.
1994-06-10
ECOFIX
ECOFIX
74128705 1747463 Dead/Cancelled
Pichat, Philippe
1991-01-08

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