FDA.report

Brasseler USA

Primary DI
00887919681106
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023313U0
Device description
CRZ CROWN SPR ZENA 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
EMRFILE, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMRFile, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919681106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919681106008879196811068879196811060887919681106

GMDN Terms

TermDefinition
Dental collar/crown scissorsA hand-held dental instrument designed to cut metal bands. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has short, robust, blades that can cut through the thin metal strips (bands). 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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