Constrictor - Syndesmosis Repair (Stainless Steel) AB-5200

GUDID 10854629006885

Constrictor - Syndesmosis Repair (Stainless Steel)

DUNAMIS MEDICAL, LLC

Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button
Primary Device ID10854629006885
NIH Device Record Key3fe0aa82-8f06-4262-a537-614a230e3fdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameConstrictor - Syndesmosis Repair (Stainless Steel)
Version Model NumberAB-5200
Catalog NumberAB-5200
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
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 Numberfalse
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

Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com
Phone334-371-6280
Emailinfo@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110854629006885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

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00850052601225 - Orca Xtreme ™ Kit Knotless Button2024-03-22 Orca Xtreme™ Kit Knotless Button
00850052601188 - Force DFX Suture-Xtreme™2024-02-08 Force DFX Suture-Xtreme™
00850052601195 - Fixation Button-Oblong2024-02-08 Fixation Button-Oblong
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