FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919504511
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5008861U0
Catalog number
5008861U0
Device description
K000032 SEQUENCE ACCESS KIT 1P
Published
2022-12-01
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
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919504511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919504511008879195045118879195045110887919504511

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. 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
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995240650V. MuellerSteris CorporationFRG2026-09-24
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20888277188256GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190426GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190453GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115498GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188270GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190440GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389188283GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190484GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115597GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
10884389192481GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196180810GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921093GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921116GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190419GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277115580GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190471GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26