Kinematic Alignment Caliper 4240-7349

GUDID 09421028112963

Intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces

ENZTEC LIMITED

Medical ruler, reusable
Primary Device ID09421028112963
NIH Device Record Key999bd07a-1f5e-4195-af80-2044570c26fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinematic Alignment Caliper
Version Model Number4240-7349
Catalog Number4240-7349
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
GS109421028112963 [Primary]

FDA Product Code

KTZCaliper

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


[09421028112963]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-21
Device Publish Date2024-10-11

Devices Manufactured by ENZTEC LIMITED

09421028112963 - Kinematic Alignment Caliper2024-10-21Intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces
09421028112963 - Kinematic Alignment Caliper2024-10-21 Intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces
09421038410080 - Enztec Trinket 3/8-16 UNC-032024-10-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410295 - Enztec Trinket M8x1.25-022024-10-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119252 - Enztec Trinket 3/8-24 UNF-032024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119900 - Enztec Trinket 5/16-24 UNF-012024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119924 - Enztec Trinket M8x1.25-012024-09-02 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115056 - Enztec Cup Impactor Alignment Guide - Supine2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028115063 - Enztec Cup Impactor Alignment Guide - Lateral2024-08-23 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.