Gorilla Plating System P53-109-L103

GUDID 00889795017932

Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Lg, TiA

PARAGON 28, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00889795017932
NIH Device Record Key436f77ad-426d-4c46-9488-a1a4c79222a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGorilla Plating System
Version Model NumberP53-109-L103
Catalog NumberP53-109-L103
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795017932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795017932]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-09-24

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00889795017468BOW Implant Caddy, Gorilla
00889795017451Lid, Half Caddy
00889795017444R3CON Screw Caddy Base and Lid, Gorilla
00889795017437Case Lid, Full DIN
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00889795017406Instrument Tray, Gorilla
00889795017390Implant Caddy Tray, Gorilla
00889795017383Case Base Assembly, Gorilla
00889795016126CADDY, ALLOGRAFT, SUB TALAR & CALC CUBOID, HALF
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00889795016102CADDY, ALLOGRAFT, EVANS AND COTTON, HALF
00889795016096Caddy, MTP Allograft, Half
00889795016089Caddy, Lid, Allograft, Half
00889795018083Mini-Monster, Washer, Ø2.7mm, Flat, TiA
00889795001122Gorilla Washer
00889795018052Gorilla, Ankle Fx, Anatomical Fibular Plate R, 17-Hole
00889795018021Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Lg, TiA
00889795018014Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Md, TiA
00889795018007Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Sm, TiA
00889795017994Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Lg, TiA
00889795017987Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Md, TiA
00889795017970Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Sm, TiA
00889795017963Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Lg, TiA
00889795017956Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Md, TiA
00889795017949Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Sm, TiA
00889795017932Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Lg, TiA
00889795017925Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Md, TiA
00889795017918Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Sm, TiA
00889795017901Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Lg, TiA
00889795017895Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Md, TiA
00889795017888Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Sm, TiA
00889795017871Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Lg, TiA
00889795017864Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Md, TiA
00889795017857Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Sm, TiA
00889795017840Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Lg, TiA
00889795017833Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Md, TiA
00889795017826Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Sm, TiA

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