MISTER Tendon Harvester P68-101-0000-SK

GUDID 00889795128751

Tendon Harvester & Dilator Sterile Kit

PARAGON 28, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00889795128751
NIH Device Record Key3cd7c95e-9aba-4099-a516-f68690d56d40
Commercial Distribution StatusIn Commercial Distribution
Brand NameMISTER Tendon Harvester
Version Model NumberP68-101-0000-SK
Catalog NumberP68-101-0000-SK
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100889795128751 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-24
Device Publish Date2024-01-16

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