MINI-LEXER, OSTEOTOME 6mm, STRAIGHT

GUDID D9281675060

W.H. Holden, Inc.

Dental osteotome
Primary Device IDD9281675060
NIH Device Record Keyf1f7b6c1-198b-4b2d-9833-c3fb1b9cb269
Commercial Distribution StatusIn Commercial Distribution
Brand NameMINI-LEXER, OSTEOTOME 6mm, STRAIGHT
Version Model Number1675-06
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
HIBCCD9281675060 [Primary]

FDA Product Code

EMMChisel, Osteotome, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


[D9281675060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-26
Device Publish Date2024-12-18

Devices Manufactured by W.H. Holden, Inc.

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D9283001110 - SCISSORS MAYO 6 3/4" STRAIGHT TC2024-12-27
D9283001120 - SCISSORS MAYO 6 3/4" CURVED TC2024-12-27
D9283001150 - SCISSORS METZENBAUM 5 3/4" STRAIGHT BLUNT TC2024-12-27
D9283001160 - SCISSORS METZ 5 3/4" CURVED TC2024-12-27

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