FDA.report

Brasseler USA

Primary DI
00887919680192
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023222U0
Device description
CHL3 HOLL 3 CARVER #2 HDL 1P
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMOKNIFE, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919680192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919680192008879196801928879196801920887919680192

GMDN Terms

TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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