FLEXBAND FIX

GUDID 10850003396214

FLEXBAND and anchor kit with paddle handle

Artelon

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID10850003396214
NIH Device Record Key9da1b3f9-ce77-4ad8-95a5-f5b9fd3c8824
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLEXBAND FIX
Version Model Number51013
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 Kittrue
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.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com
Phone(800) 610-3446
Emailtiffini.wittwer@artelon.com

Device Dimensions

Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003396217 [Primary]
GS110850003396214 [Package]
Contains: 00850003396217
Package: Carton [5 Units]
In Commercial Distribution

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

[10850003396214]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-01
Device Publish Date2023-05-24

Devices Manufactured by Artelon

00850003396248 - Twist Kit2024-04-19 Flexband 12cm device with anchors and instruments kit
00850003396323 - Twist Kit2024-04-19 Flexband 30cm device with anchors and instruments kit
00850003396347 - Twist Driver Kit2024-04-19 Twist 5.0mm Anchor on Driver.
00850003396330 - Twist Driver Kit2024-04-18 Twist 3.85mm Anchor on Driver.
00850003396187 - FlexBand Plus2023-06-01 FlexBand Plus 0.5 x 24 Strip with Suture
00850003396200 - DRILL BIT AND GUIDE2023-06-01 Cannulated Drill Bit and Guide
10850003396214 - FLEXBAND FIX2023-06-01FLEXBAND and anchor kit with paddle handle
10850003396214 - FLEXBAND FIX2023-06-01 FLEXBAND and anchor kit with paddle handle
00850003396255 - FlexBand Eyelet Anchor2023-06-01 Hex Eyelet Anchor
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