CMC Spacer DNS000/DNS001

GUDID 00850052601089

CMC Spacer

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 ID00850052601089
NIH Device Record Key13aa183a-30e9-443e-a15c-0a4d485b4d5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCMC Spacer
Version Model NumberDNS000/DNS001
Catalog NumberDNS000/DNS001
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
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
GS100850052601089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-18
Device Publish Date2024-06-10

Devices Manufactured by DUNAMIS MEDICAL, LLC

00850052601249 - Orca™ Implantation Kit 2024-06-28 Orca™ Implantation Kit
00850052601072 - Hallux Guide2024-06-18 Hallux Guide
00850052601089 - CMC Spacer2024-06-18CMC Spacer
00850052601089 - CMC Spacer2024-06-18 CMC Spacer
00850052601096 - CMC Guide2024-06-18 CMC Guide
00850052601157 - Threaded Driver 2024-06-18 Threaded Driver
00850052601232 - Micro Constrictor® Implantation Kit 2024-06-18 Micro Constrictor® Implantation Kit
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™
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