Monkey Rings™ External Fixation System P45-233-1000

GUDID 00889795128409

MODULAR BALL JOINT

PARAGON 28, INC.

External orthopaedic fixation system, single-use
Primary Device ID00889795128409
NIH Device Record Key9ebe881a-39b6-459c-bd42-e126e020932a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonkey Rings™ External Fixation System
Version Model NumberP45-233-1000
Catalog NumberP45-233-1000
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
GS100889795128409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


[00889795128409]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-02
Device Publish Date2023-07-25

On-Brand Devices [Monkey Rings™ External Fixation System]

00889795123961Strut Locking Clip (Bag of 10)
00889795121431Rapid Nut Allen Wrench
00889795120977Case 3 Fasterner Caddy
00889795120960Case 3 K-Wire Caddy
00889795120953Tubular Wrench, 10mm
00889795120915Case Base, Case 2 of 4
00889795120908Case Dishwasher, Case 1 of 4
00889795118998Spherical Washer (Pair) Bottom
00889795118981Spherical Washer (Pair) TOP
00889795118974Rancho Cube, Ø6.0 Centering Collar
00889795118967Wire Bolt, Offset & Center hole
00889795118004Anti Microbial pads
00889795117991Ø6.0mm Half Pin Quick Connect (SP1306)
00889795117984Ø5.0mm Half Pin Quick Connect (SP1305)
00889795117977Ø4.0mm Half Pin Quick Connect (SF1304)
00889795117960Ø3.2mm x 195mm Drill for HA Half Pins (SF1324)
00889795117953Half Pin, Self Drilling, Ø6.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST156180HA)
00889795117946Half Pin, Self Drilling, Ø5.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST145180HA)
00889795117939Half Pin, Self Drilling, Ø4.0mm x 34mm, 120mm SHANK LENGTH, HA COATED (ST134120HA)
00889795117922Wire Cutter
00889795117915Tang Angled Socket Wrench, 10mm
00889795117908Speed Nut
00889795116611Protective Cap, 6.0
00889795116604Protective Cap, 5.0
00889795116598Protective Cap, 4.0
00889795116581Foot Rocker Kit
00889795116567Tray 1, Case 4 of 5
00889795116550Case Base, Case 4 of 5
00889795116505Pin Cutter
00889795116482Hex Driver on T Handle
00889795116444Slotted Angled Socket Wrench, 10mm
00889795116437Angled Socket Wrench, 10mm
00889795116376Extension Post, 5 hole
00889795116369Extension Post, 2 hole
00889795116352Rancho Cube, Ø5.0 Centering Collar
00889795116345Rancho Cube, Ø4.0 Centering Collar
00889795116338Rancho Cube, 5 hole
00889795116321Rancho Cube, 4 hole
00889795116314Rancho Cube, 3 hole
00889795116307Rancho Cube, 2 hole
00889795116284Post, 4 hole
00889795116277Post, 3 hole
00889795116260Post, 2 hole
00889795116246Female Post, 4 hole
00889795116239Female Post, 3 hole
00889795116222Female Post, 2 hole
00889795116208Universal Pin Clamp
00889795116185Washer, 4mm
00889795116178Washer, 2mm
00889795116161Washer, 1mm

Trademark Results [Monkey Rings]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MONKEY RINGS
MONKEY RINGS
97273969 not registered Live/Pending
Paragon 28, Inc.
2022-02-18

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