FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919684213
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023635U0
Device description
GK15/166 KIRKLAND 15/16 #6 HDL
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

Product Codes#

Code, Name table
CodeName
EKDINSTRUMENT, CUTTING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919684213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919684213008879196842138879196842130887919684213

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
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
07392532229480FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10