Fastloop™ Green

GUDID 00854629006857

Polyester Suture Loop Green with Needle

DUNAMIS MEDICAL, LLC

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament
Primary Device ID00854629006857
NIH Device Record Keydf5f5271-93c3-4558-bce6-983208ac40a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameFastloop™ Green
Version Model NumberDFX24SLG
Company DUNS079471560
Company NameDUNAMIS MEDICAL, LLC
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com
Phone877.454.2186
Emailinfo@dunamismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854629006857 [Unit of Use]
GS110854629006854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-11
Device Publish Date2022-03-03

Devices Manufactured by DUNAMIS MEDICAL, LLC

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
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 Loop2023-08-25 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)

Trademark Results [Fastloop]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FASTLOOP
FASTLOOP
90905400 not registered Live/Pending
Dunamis Medical Technologies, LLC
2021-08-26
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