SA-FB6

GUDID M944SAFB60

WEXLER SURGICAL, INC.

Diamond ENT bur, single-use
Primary Device IDM944SAFB60
NIH Device Record Key4dba33d3-9fc1-4b58-8d19-199707e80c2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSA-FB6
Version Model NumberSA-FB6
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
GS100840240937540 [Secondary]
HIBCCM944SAFB60 [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 Date2025-02-24
Device Publish Date2025-02-14

Devices Manufactured by WEXLER SURGICAL, INC.

00840240937618 - SA-C-FB4L2025-02-24
00840240937571 - SA-C-FB52025-02-24
00840240937557 - SA-DB1L2025-02-24
00840240937533 - SA-DB2L2025-02-24
00840240937649 - SA-DB32025-02-24
00840240937625 - SA-DB3L2025-02-24
00840240937656 - SA-DB42025-02-24
00840240937632 - SA-DB4L2025-02-24

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