Reamer Driver Lock Ring 4250-7111

GUDID 09421028118989

A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Surgical power tool adaptor
Primary Device ID09421028118989
NIH Device Record Keyd0e8cee6-062a-4ecf-a577-33fe8fa38668
Commercial Distribution StatusIn Commercial Distribution
Brand NameReamer Driver Lock Ring
Version Model Number4250-7111
Catalog Number4250-7111
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
GS109421028118989 [Primary]

FDA Product Code

HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


[09421028118989]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-23
Device Publish Date2024-01-15

Devices Manufactured by ENZTEC LIMITED

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09421028118651 - Adjustable Cutting Block – 1.35mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118668 - 3.5mm Ball Hex Driver – 340mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119030 - Adjustable Cutting Block – 1.27mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119085 - MODULAR BROACH HANDLE, GRIP2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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