Tenodesis Screw System P41-040-1500-S

GUDID 00889795053695

Grappler PEEK Interference Screw 4 x 15mm

PARAGON 28, INC.

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00889795053695
NIH Device Record Keya6f1706c-622a-47b1-b127-83fefdcfe772
Commercial Distribution StatusIn Commercial Distribution
Brand NameTenodesis Screw System
Version Model NumberP41-040-1500-S
Catalog NumberP41-040-1500-S
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795053695 [Primary]

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 Date2019-10-25
Device Publish Date2019-10-17

On-Brand Devices [Tenodesis Screw System]

00889795057587Grappler Interference Screw, Caddy Lid
00889795057570Grappler Interference Screw Instruments, Caddy
00889795057556Grappler Interference Depth Gauge, 25mm
00889795057549Screw Driver Attachment 7.0/8.0mm, Solid , A/O, Trilobe, Grappler
00889795057532Screw Driver Attachment 5.5/6.0mm, Solid , A/O, Trilobe, Grappler
00889795057525Screw Driver Attachment 4.5/5.0mm, Solid , A/O, Trilobe, Grappler
00889795057518Screw Driver Attachment 4.0mm, Solid, A/O, Trilobe, Grappler
00889795057501Tissue Protector Insert 8.5, Grappler
00889795057495Tissue Protector Insert 8.0, Grappler
00889795057488Tissue Protector Insert 7.5, Grappler
00889795057471Tissue Protector Insert 7.0, Grappler
00889795057464Tissue Protector Insert 6.5, Grappler
00889795057457Tissue Protector Insert 6.0, Grappler
00889795057440Tissue Protector Insert 5.5, Grappler
00889795057433Tissue Protector Insert 5.0, Grappler
00889795057426Tissue Protector Insert 4.5, Grappler
00889795057419Tissue Protector Insert 4.0, Grappler
00889795057402Tissue Protector Handle, Grappler
00889795057396Tendon Sizer, Grappler
00889795053879Grappler PEEK Interference Screw 8 x 25mm
00889795053862Grappler PEEK Interference Screw 8 x 20mm
00889795053855Grappler PEEK Interference Screw 7 x 25mm
00889795053848Grappler PEEK Interference Screw 7 x 20mm
00889795053831Grappler PEEK Interference Screw 6 x 25mm
00889795053824Grappler PEEK Interference Screw 6 x 20mm
00889795053817Grappler PEEK Interference Screw 6 x 15mm
00889795053800Grappler PEEK Interference Screw 5.5 x 25mm
00889795053794Grappler PEEK Interference Screw 5.5 x 20mm
00889795053787Grappler PEEK Interference Screw 5.5 x 15mm
00889795053770Grappler PEEK Interference Screw 5 x 25mm
00889795053763Grappler PEEK Interference Screw 5 x 20mm
00889795053756Grappler PEEK Interference Screw 5 x 15mm
00889795053749Grappler PEEK Interference Screw 5 x 10mm
00889795053732Grappler PEEK Interference Screw 4.5 x 20mm
00889795053725Grappler PEEK Interference Screw 4.5 x 15mm
00889795053718Grappler PEEK Interference Screw 4.5 x 10 mm
00889795053701Grappler PEEK Interference Screw 4 x 20mm
00889795053695Grappler PEEK Interference Screw 4 x 15mm
00889795053688Grappler PEEK Interference Screw 4 x 10mm
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