FDA.report

Brasseler USA

Primary DI
00887919683452
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023548U0
Device description
EXEDG16/166 ENDO EXPL #6 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
EKBEXPLORER, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919683452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919683452008879196834528879196834520887919683452

GMDN Terms

TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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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