FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919684930
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023707U0
Device description
C24 SPATULA FLEX 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

Product Codes#

Code, Name table
CodeName
EIKCARVER, WAX, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919684930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919684930008879196849308879196849300887919684930

GMDN Terms#

Term, Definition table
TermDefinition
Salivary gland dilator, reusableA surgical instrument used during ear/nose/throat (ENT) surgery for enlarging a salivary gland cavity, canal, or duct, typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure. It is rod-like device, with a long, very slender body and a rounded nose at its distal end, that is made of metal (e.g., stainless steel). 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
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
00840018666016Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-09
00840018663671Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665293Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665439Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665446Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018663305Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-29
00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00813677024145PDT, Inc.PDT, INC.EIK2024-06-27
00813677024152PDT, Inc.PDT, INC.EIK2024-06-27
00813677024169PDT, Inc.PDT, INC.EIK2024-06-27
00813677024176PDT, Inc.PDT, INC.EIK2024-06-27
00813677024183PDT, Inc.PDT, INC.EIK2024-06-27
00310866002644GET SCULPTEDPASCAL COMPANY, INC.EIK2024-05-16
00842517119352Karl SchumacherKarl Schumacher Dental, LLCEIK2024-05-06
08800075626479OSUNG MNDOSUNG MND Co., Ltd.EIK2024-03-06
08800075626516OSUNG MNDOSUNG MND Co., Ltd.EIK2024-03-06
08800075626486OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626493OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626509OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626523OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
G1577046890PomeePOMEE CORPORATIONEIK2023-10-16
G1577132500PomeePOMEE CORPORATIONEIK2023-10-11
G1577132700PomeePOMEE CORPORATIONEIK2023-10-11
G1577132750PomeePOMEE CORPORATIONEIK2023-10-11
G1577132770PomeePOMEE CORPORATIONEIK2023-10-11
G1577133030PomeePOMEE CORPORATIONEIK2023-10-11