SA-DB3L

GUDID 00840240937625

WEXLER SURGICAL, INC.

Diamond ENT bur, single-use
Primary Device ID00840240937625
NIH Device Record Key0d682bac-9909-47d4-a07a-15f57b4f0391
Commercial Distribution StatusIn Commercial Distribution
Brand NameSA-DB3L
Version Model NumberSA-DB3L
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
GS100840240937625 [Secondary]
HIBCCM944SADB3L0 [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
00840240937625 - SA-DB3L2025-02-24
00840240937656 - SA-DB42025-02-24
00840240937632 - SA-DB4L2025-02-24

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