JAWS Staple System P70-294-2006

GUDID 00889795114143

JAW STAPLE SYS, SMOOTH LOC PIN

PARAGON 28, INC.

Cannulated surgical drill guiding pin
Primary Device ID00889795114143
NIH Device Record Key253b6037-e5ee-44a6-9117-b9965d5bbad4
Commercial Distribution StatusIn Commercial Distribution
Brand NameJAWS Staple System
Version Model NumberP70-294-2006
Catalog NumberP70-294-2006
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
GS100889795114143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


[00889795114143]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-24
Device Publish Date2022-10-14

On-Brand Devices [JAWS Staple System]

00889795049834JAWS Trial Sizer 20mm and 25mm
00889795049827JAWS Trial Sizer 15mm and 18mm
00889795049810JAWS Trial Sizer 8mm and 10mm
00889795049803JAWS Staple Instrument Caddy, Lid
00889795049797JAWS Staple Intrument Caddy, Base
00889795114143JAW STAPLE SYS, SMOOTH LOC PIN
00889795114082JAWS Staple, 12mm, 12 x 12 Straight

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