PROCOTYL® P ENZTEC OFFSET HANDLE PPENZOFF

GUDID 09421028118958

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Orthopaedic implant impactor, reusable
Primary Device ID09421028118958
NIH Device Record Key0d77e435-b029-4109-8af9-df692875b3bb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROCOTYL® P ENZTEC OFFSET HANDLE
Version Model NumberPPENZOFF
Catalog NumberPPENZOFF
Company DUNS592616445
Company NameENZTEC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109421028118958 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


[09421028118958]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

Devices Manufactured by ENZTEC LIMITED

09421028119269 - LEGION Kinematic Alignment Distal Valgus Guide2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119276 - JOURNEY Kinematic Alignment Distal Valgus Guide - Left2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119283 - JOURNEY Kinematic Alignment Distal Valgus Guide - Right2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119290 - Kinematic Alignment Caliper – S+N2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119306 - Distal Cartilage Shim – 2mm2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119313 - Varus/Valgus Recut Block – 2deg2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119382 - Spiked EM/IM 3 Degree Left Tibia Cutting Block2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119399 - Spiked EM/IM 3 Degree Right Tibia Cutting Block2025-02-03 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

Trademark Results [PROCOTYL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROCOTYL
PROCOTYL
78558986 3163841 Live/Registered
Wright Medical Technology, Inc.
2005-02-02

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