Suture Passer - Single Loop DM-4890

GUDID 00850052601041

Suture Passer - Single Loop

DUNAMIS MEDICAL, LLC

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Primary Device ID00850052601041
NIH Device Record Key3feed46e-c245-4141-8190-b14c2472bb9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuture Passer - Single Loop
Version Model NumberDM-4890
Catalog NumberDM-4890
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Phone334-371-6280
Emailinfo@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850052601041 [Primary]

FDA Product Code

HWQPasser

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-25
Device Publish Date2023-08-17

Devices Manufactured by DUNAMIS MEDICAL, LLC

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00850052601195 - Fixation Button-Oblong2024-02-08 Fixation Button-Oblong
20854629006912 - Orca™ Mini Knotless Button2024-02-08 Orca™ Mini Knotless Button
30854629006919 - Orca™ XL Knotless Tendon Repair2024-02-08 Orca™ XL Knotless Tendon Repair
40854629006916 - Orca™ Xtreme Knotless Button2024-02-08 Orca™ Xtreme Knotless Button
00850052601041 - Suture Passer - Single Loop2023-08-25Suture Passer - Single Loop
00850052601041 - Suture Passer - Single Loop2023-08-25 Suture Passer - Single Loop
00854629006321 - 5.5mm PunchTac™ Threaded Anchor PEEK2023-08-25 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm Fiber Connect (UHMWPE)

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