FDA.report

QUALA

Primary DI
D023QRBL451
Brand
QUALA
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
QRBL45
Catalog number
QRBL45
Device description
QUALA RONGEUR-BLUMENTHAL 45DEG 6
Published
2022-09-25
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
EKDInstrument, Cutting, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D023QRBL451PrimaryHIBCC0

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
009831413
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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M220P5420075PRO ADVANTAGE P542007P5420072018-09-23
M22P5420105PRO ADVANTAGEP542010P5420102018-09-23
M220P5420125PRO ADVANTAGEP542012P5420122018-09-23
M220P5420155PRO ADVANTAGEP542015P5420152018-09-23
M220P5420175PRO ADVANTAGEP542017P5420172018-09-23
M220P5420205PRO ADVANTAGEP542020P5420202018-09-23
M220P5420225PRO ADVANTAGEP542022P5420222018-09-23
M220P5420255PRO ADVANTAGEP542025P5420252018-09-23
M220P5420275PRO ADVANTAGEP542027P5420272018-09-23
M220P5420295PRO ADVANTAGEP542029P5420292018-09-23
M220P5420305PRO ADVANTAGEP542030P5420302018-09-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07897990302343MICROCUT MANUALTDV DENTAL LTDAEKD2025-03-04
07897990311789MICROCUT MANUALTDV DENTAL LTDAEKD2025-03-04
07897990302312MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990302329MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990302336MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990332401MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990334078MICROCUTTDV DENTAL LTDAEKD2025-02-28
00885797096340RMORmo, Inc.EKD2024-08-13
00842517118713Karl SchumacherKarl Schumacher Dental, LLCEKD2024-05-06
00842517118720Karl SchumacherKarl Schumacher Dental, LLCEKD2024-05-06
07898506811793QuinelatoSchobell Industrial LtdaEKD2023-07-05
10889950110352Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKD2023-06-27
00190776362522MillenniumAVALIGN TECHNOLOGIES, INC.EKD2023-02-22
E8963438100SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
E8963439100SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
E8963439130SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
00887919684213Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-08
00887919198635Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198680Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198727Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198987Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919199892Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919199922Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919202851Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919202899Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919203100Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919203117Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
07898506811106QuinelatoSchobell Industrial LtdaEKD2022-11-28
07898506839315QuinelatoSchobell Industrial LtdaEKD2022-11-28
07898506841509QuinelatoSchobell Industrial LtdaEKD2022-11-28