Wexler Surgical, Inc.

GUDID 00840240938073

WEXLER SURGICAL, INC.

Diamond ENT bur, single-use
Primary Device ID00840240938073
NIH Device Record Key416eae3a-7398-4a03-a1c0-ac49e3944d30
Commercial Distribution StatusIn Commercial Distribution
Brand NameWexler Surgical, Inc.
Version Model NumberLA-FM3U
Company DUNS024882552
Company NameWEXLER SURGICAL, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100840240938073 [Secondary]
HIBCCM944LAFM3U0 [Primary]

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-07
Device Publish Date2025-03-28

On-Brand Devices [Wexler Surgical, Inc.]

M944VL021240VL0212.4
M944VL021140VL0211.4
M944VL020640VL0206.4
M944VL020540VL0205.4
M944VL020240VL0202.4
M944VL020140VL0201.4
M944TL011510TL0115.1
M944TL011410TL0114.1
M944AL012410AL0124.1
M944AL012210AL0122.1
M944AL012010AL0120.1
M944AL004030AL0040.3
M944AL004010AL0040.1
M944FL4047210FL4047.21
M944FL4046210FL4046.21
M944FL4045210FL4045.21
M944FL4044210FL4044.21
M944DL913020DL9130.2
M944DL912820DL9128.2
M944DL911020DL9110.2
M944DL910920DL9109.2
M944DL910820DL9108.2
M944AL116010AL1160.1
M944AL115610AL1156.1
M944AL115510AL1155.1
M944AL115410AL1154.1
M944AL115210AL1152.1
M944AL115010AL1150.1
M944AL111210AL1112.1
M944AL111110AL1111.1
M944AL110010AL1100.1
M944AL107830AL1078.3
M944AL107430AL1074.3
M944AL107210AL1072.1
M944AL107030AL1070.3
M944AL103510AL1035.1
M944AL103410AL1034.1
M944AL005510AL0055.1
M944AL005410AL0054.1
M944AL005310AL0053.1
M944AL005210AL0052.1
M944AL005110AL0051.1
M944AL005010AL0050.1
M944AL004810AL0048.1
M944AL002520AL0025.2
M944AL001920AL0019.2
M944AL001720AL0017.2
M944AL001620AL0016.2
M944FL8614120FL8614.12
M944SL87201H0SL8720.1H

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