Enztec Reamer 70mm - Bridgeback 4250-9970

GUDID 09421038413067

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

ENZTEC LIMITED

Acetabular orthopaedic reamer
Primary Device ID09421038413067
NIH Device Record Key33364888-9cd0-4693-8fba-a3bd2a992653
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Reamer 70mm - Bridgeback
Version Model Number4250-9970
Catalog Number4250-9970
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
GS109421038413067 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


[09421038413067]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-03
Device Publish Date2026-02-23

Devices Manufactured by ENZTEC LIMITED

09421038412145 - Cup reamer handle, offset, Z/H, locking2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412152 - Offset coupling, Z/H2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412169 - Offset drive train, locking2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412176 - Short Offset Cover – United2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412183 - Handle – United2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412299 - Cup reamer handle, offset, AO, locking2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412305 - Offset coupling, AO2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
09421038412312 - Cup reamer handle, offset, AO, open2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.