Wexler Surgical, Inc.

GUDID 00840240937885

WEXLER SURGICAL, INC.

Diamond ENT bur, single-use
Primary Device ID00840240937885
NIH Device Record Key9ca4ab30-0605-4ec8-9877-f0ec4680a15e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWexler Surgical, Inc.
Version Model NumberSA-DB15L
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
GS100840240937885 [Secondary]
HIBCCM944SADB15L0 [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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