SINUS INSTRUMENT #2 HD D/E

GUDID D9281051992HD0

W.H. Holden, Inc.

Dental osteotome set
Primary Device IDD9281051992HD0
NIH Device Record Key3043ec44-5a01-4773-a692-6a12c6d4b056
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINUS INSTRUMENT #2 HD D/E
Version Model Number10-5199-2HD
Company DUNS183854322
Company NameW.H. Holden, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD9281051992HD0 [Primary]

FDA Product Code

GFIOsteotome, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


[D9281051992HD0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by W.H. Holden, Inc.

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D9282516571500 - MICRO TISSUE FORCEPS STRAIGHT JAW2025-04-17 MICRO TISSUE FORCEPS STRAIGHT JAW, COUNTERBALANCE 6MM DIAMOND DUSTED PLATFORM, 0.7MM 9MM ROUND
D9282524101300 - TAKAHASHI ETHMOIDAL FORCEPS STRAIGHT, OVAL, CUP-SHAPED, 2MM, 4 3/4"2025-04-17
D9283101101600 - BABCOCK INTESTINAL TISSUE FORCEPS, 16.0 CM (6 1/4”)2025-04-17
D9281041150 - ELEVATOR ARROWHEAD2025-04-08
D9281051992HD0 - SINUS INSTRUMENT #2 HD D/E2025-04-02
D9281051992HD0 - SINUS INSTRUMENT #2 HD D/E2025-04-02
D928105382010 - BONE CHISEL 2.5MM, 6" S/E2025-03-27

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