Typenex Medical 097511

GUDID 02816901023677

Weinert Fiber Optics, Inc.

General/multiple surgical diode laser system
Primary Device ID02816901023677
NIH Device Record Keyb2e3d682-2bc8-4b0b-85e7-ad05df4b9cd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTypenex Medical
Version Model NumberNV0634
Catalog Number097511
Company DUNS039281260
Company NameWeinert Fiber Optics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816901023679 [Primary]
GS101816901023678 [Package]
Contains: 00816901023679
Package: [5 Units]
In Commercial Distribution
GS102816901023677 [Package]
Contains: 01816901023678
Package: [2 Units]
In Commercial Distribution

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-01
Device Publish Date2025-03-24

On-Brand Devices [Typenex Medical]

02816901022564NV0634
02816901023660NV0632
02816901023677NV0634

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