Enztec Hohmann Narrow Long Retractor 4000-0003

GUDID 09421028116329

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

ENZTEC LIMITED

Hand-held surgical retractor, reusable
Primary Device ID09421028116329
NIH Device Record Keya4899e26-4b73-4088-941c-9fdfb85d605b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnztec Hohmann Narrow Long Retractor
Version Model Number4000-0003
Catalog Number4000-0003
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
GS109421028116329 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


[09421028116329]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-07
Device Publish Date2024-01-30

Devices Manufactured by ENZTEC LIMITED

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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
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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

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