Typenex Medical 097509

GUDID 02816901023660

Weinert Fiber Optics, Inc.

General/multiple surgical diode laser system
Primary Device ID02816901023660
NIH Device Record Key9d2e63c7-6ac8-4e08-833b-05dc699a05f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTypenex Medical
Version Model NumberNV0632
Catalog Number097509
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
GS100816901023662 [Primary]
GS101816901023661 [Package]
Contains: 00816901023662
Package: [5 Units]
In Commercial Distribution
GS102816901023660 [Package]
Contains: 01816901023661
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 Date2024-11-11
Device Publish Date2024-11-03

On-Brand Devices [Typenex Medical]

02816901022564NV0634
02816901023660NV0632
02816901023677NV0634

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