FlexBand Eyelet Anchor 81001

GUDID 00850003396149

Artelon

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00850003396149
NIH Device Record Key8366d31e-acb6-4394-b0ec-200ae4a10dd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexBand Eyelet Anchor
Version Model Number81001
Catalog Number81001
Company DUNS066284070
Company NameArtelon
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com
Phone(800) 610-3446
Emailtiffini.wittewr@artelon.com

Device Dimensions

Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter
Length17 Millimeter
Outer Diameter3.85 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003396149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

[00850003396149]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-05
Device Publish Date2021-02-25

On-Brand Devices [FlexBand Eyelet Anchor]

0085000339614981001
00850003396262Hex Eyelet Anchor
00850003396255Hex Eyelet Anchor
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