X-Twist PEEK XT25503

GUDID 00816342025379

X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, black

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342025379
NIH Device Record Key0c67039e-237a-496b-84eb-f9af1625487c
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Twist PEEK
Version Model NumberXT25503
Catalog NumberXT25503
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

Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com
Phone9417557965
EmailParcusCS@Anika.com

Device Dimensions

Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342025379 [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 Date2022-07-21
Device Publish Date2022-07-13

On-Brand Devices [X-Twist PEEK]

00816342025386X-Twist PEEK 6.25mm suture anchor, 1 x No 2 suture
00816342025379X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, black
00816342025362X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes, blue
00816342025355X-Twist PEEK 5.5mm suture anchor, 1 x No 2 suture
00816342025348X-Twist PEEK 4.75mm suture anchor, 2 x 1.6mm tapes, black
00816342025331X-Twist PEEK 4.75mm suture anchor, 2 x 1.6mm tapes, blue
00816342025324X-Twist PEEK 5.5mm suture anchor, 2 x 1.6mm tapes
00816342025317X-Twist PEEK 4.75mm suture anchor, 1 x No 2 suture
00816342025300X-Twist PEEK suture anchor, 1 x 1.6mm tape

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