Draw Tight 11034

GUDID 00816342024099

Draw Tight DEX Suture Anchor w/1 1.6mm Suture Tape with Needles

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342024099
NIH Device Record Key51ec6530-4f53-4318-a6e3-02b218dae09e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDraw Tight
Version Model Number11034
Catalog Number11034
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
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

Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342024099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

On-Brand Devices [Draw Tight]

M685105880Draw Tight 3.2mm Double Loaded
M685105650Draw Tight 1.8mm Single Loaded
M6851129701.8mm Draw Tight Suture Anchor with One Suture Tape
M6851128903.2mm Draw Tight Suture Anchor with Two Suture Tapes
M6851128803.2mm Draw Tight Suture Anchor with Two Suture Tapes
00816342024099Draw Tight DEX Suture Anchor w/1 1.6mm Suture Tape with Needles
00816342021562Draw Tight 3.2mm Double Loaded
00816342021548Draw Tight 1.8mm Single Loaded

Trademark Results [Draw Tight]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DRAW TIGHT
DRAW TIGHT
98001181 not registered Live/Pending
Anika Therapeutics, Inc.
2023-05-17

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