10mm x 10mm x 10mm Staple

GUDID 00812926028224

TRILLIANT SURGICAL, LTD.

Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable, non-sterile
Primary Device ID00812926028224
NIH Device Record Key013d5317-47e7-413e-ae78-61583d2cb08e
Commercial Distribution StatusIn Commercial Distribution
Brand Name10mm x 10mm x 10mm Staple
Version Model Number500-10-101
Company DUNS828829072
Company NameTRILLIANT SURGICAL, LTD.
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

Width10 Millimeter
Width10 Millimeter
Width10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter
Height10 Millimeter
Width10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812926028224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


[00812926028224]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-05

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