FDA.report

Paul Banditt

Primary DI
D955RONM1
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
RONM
Device description
PAUL BANDITT "M" RONGEURS, 15.5cm, "Micro Friedmann" | mod. | 30°
Published
2023-12-11
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
EMHForceps, Rongeur, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D955RONM1PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
177465051
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
false
Sterilization required before use
true

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D955BCUM11Paul BandittBCUM1 2023-12-11
D955BCUM21Paul BandittBCUM2 2023-12-11
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D955BCUM31Paul BandittBCUM3 2023-12-11
D955BCUM41Paul BandittBCUM4 2023-12-11
D955BCUM7L1Paul BandittBCUM7L 2023-12-11

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