Twist Kit

GUDID 00850003396248

Flexband 12cm device with anchors and instruments kit

Artelon

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00850003396248
NIH Device Record Key77fd0c2d-8fac-4ad1-98ff-4df00f3129d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwist Kit
Version Model NumberTW012
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 Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003396248 [Primary]

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


[00850003396248]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-19
Device Publish Date2024-04-11

Devices Manufactured by Artelon

00850003396248 - Twist Kit2024-04-19Flexband 12cm device with anchors and instruments kit
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 FIX2023-06-01 FLEXBAND and anchor kit with paddle handle
00850003396255 - FlexBand Eyelet Anchor2023-06-01 Hex Eyelet Anchor

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.