FDA.report

Power Dental USA

Primary DI
D9434209
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
4209
Catalog number
4209
Device description
BONE CHISELS C4
Published
2021-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMLCHISEL, BONE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9434209PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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D943DCAM0Power Dental USADCAMDCAM2021-07-13
D943DCAM30Power Dental USADCAM3DCAM32021-07-13
D943KIM10Power Dental USAKIM-1KIM-12022-07-12
D943KIM120Power Dental USAKIM-12KIM-122022-07-12
D943KIM20Power Dental USAKIM-2KIM-22022-07-12
D943KIM240Power Dental USAKIM-24KIM-242021-07-13
D943KIM30Power Dental USAKIM-3KIM-32022-07-12

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