FDA.report

PRODONT-HOLLIGER

Primary DI
03665224022091
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
406.08SI
Catalog number
406.08SI
Device description
instr.dble n128-l5 bliss
Published
2021-11-19
Public version status
New
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
EMNScaler, Periodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03665224022091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03665224022091036652240220913665224022091

GMDN Terms

TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275499887
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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03665224000099PRODONT-HOLLIGERMZP521MZP5212021-11-19
03665224000129PRODONT-HOLLIGERMZP531MZP5312021-11-19
03665224000150PRODONT-HOLLIGERMZP541MZP5412021-11-19
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03665224000679PRODONT-HOLLIGER1290.021290.022021-11-19
03665224000686PRODONT-HOLLIGER1290.041290.042021-11-19
03665224000693PRODONT-HOLLIGER1290.071290.072021-11-19
03665224000709PRODONT-HOLLIGER1290.081290.082021-11-19
03665224000716PRODONT-HOLLIGER1290.131290.132021-11-19
03665224000723PRODONT-HOLLIGER1290.171290.172021-11-19
03665224000730PRODONT-HOLLIGER1290.181290.182021-11-19
03665224000747PRODONT-HOLLIGER1290.211290.212021-11-19
03665224000754PRODONT-HOLLIGER1290.221290.222021-11-19
03665224000761PRODONT-HOLLIGER1290.331290.332021-11-19
03665224000778PRODONT-HOLLIGER1290.511290.512021-11-19
03665224000785PRODONT-HOLLIGER1290.731290.732021-11-19
03665224000792PRODONT-HOLLIGER1290.751290.752021-11-19
03665224000808PRODONT-HOLLIGER1290.791290.792021-11-19

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