PERIO KNIFE GOLDMAN FOX 7 CH HANDLE

GUDID D9284001000

W.H. Holden, Inc.

Periodontal knife
Primary Device IDD9284001000
NIH Device Record Keyd38b66e2-b277-41fa-9c29-96095b2a338d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERIO KNIFE GOLDMAN FOX 7 CH HANDLE
Version Model Number40-0100
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
HIBCCD9284001000 [Primary]

FDA Product Code

EMOKnife, Periodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


[D9284001000]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-10
Device Publish Date2025-01-31

Devices Manufactured by W.H. Holden, Inc.

D928400527H0 - POWERTOME S/E HF HANDLE2026-02-04
D928106122R450 - SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE2026-01-23
D9281059552HF570 - CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG2026-01-22
D928400101CH0 - PERIO KNIFE GOLDMAN FOX 8 CH HANDLE2026-01-22
D928400102CH0 - PERIO KNIFE GOLDMAN FOX 11 CH HANDLE2026-01-22
D928400102HF0 - PERIO KNIFE GOLDMAN FOX 11 HF HANDLE2026-01-22
D928400102R0 - PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE2026-01-22
D9284001040 - D92840010402026-01-22

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