Tibial Impactor Tips

GUDID 00850062461949

Trilliant Surgical, LLC

Orthopaedic implant impactor, reusable
Primary Device ID00850062461949
NIH Device Record Key5ad92821-bb09-4a73-9d2f-0517b9296a3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Impactor Tips
Version Model Number920-0061-04
Company DUNS828829072
Company NameTrilliant Surgical, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850062461949 [Primary]

FDA Product Code

NTGProsthesis, Ankle, Uncemented, Non-Constrained

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


[00850062461949]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-19
Device Publish Date2024-08-09

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00810028394438 - Instrument Case #3, Gen II STAR Ankle 2024-11-11
00810028394445 - Right Talar Cut Guide Assy, Gen II STAR Ankle2024-11-11
00810028394452 - Talar Cut Guide Caddy Lid, Gen II STAR Ankle 2024-11-11
00810028394469 - Left Talar Cut Guide Caddy Assy, Gen II STAR Ankle 2024-11-11
00810028394476 - PE Trial Caddy Assy, Gen II 2024-11-11
00810028394483 - PE Trial Caddy Lid, Gen II STAR Ankle 2024-11-11
00810028394490 - Spare Caddy, Gen II STAR Ankle 2024-11-11

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