FDA.report

Brasseler USA

Primary DI
00887919683353
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023538U0
Device description
EXCE33L4 ENDO EXCAV #4 HDL 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

Related Records

Product Codes

CodeName
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919683353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919683353008879196833538879196833530887919683353

GMDN Terms

TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods

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

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08404535019247Brasseler USA5031780U05031780U02026-03-24
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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

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00840018662575Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-29
00840018661394Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-28
05010058178113InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
05010058182691InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
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00889813065402Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
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00813677024503PDT, Inc.PDT, INC.EKC2024-06-27
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