FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919921608
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5029442U0
Catalog number
5029442U0
Device description
HOWARD ENDO FILE KIT SB 1P
Published
2023-01-25
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
NYDendodontic Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYDEndodontic KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919921608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919921608008879199216088879199216080887919921608

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00887919504511Brasseler USA5008861U05008861U02022-12-01
00887919581611DENTFLEX FIBER POST5013908U05013908U02022-12-01
00887919581628DENTFLEX FIBER POST5013909U05013909U02022-12-01
00887919581635DENTFLEX FIBER POST5013910U05013910U02022-12-01
00887919581642DENTFLEX FIBER POST5013911U05013911U02022-12-01
00887919581659DENTFLEX FIBER POST5013912U05013912U02022-12-01
00887919581666DENTFLEX FIBER POST5013913U05013913U02022-12-01
00887919581673DENTFLEX FIBER POST5013914U05013914U02022-12-01
00887919581680DENTFLEX FIBER POST5013915U05013915U02022-12-01
00887919581697DENTFLEX FIBER POST5013916U05013916U02022-12-01
00887919581710DENTFLEX FIBER POST5013917U05013917U02022-12-01
00887919581734DENTFLEX FIBER POST5013918U05013918U02022-12-01
00887919581758DENTFLEX FIBER POST5013919U05013919U02022-12-01
00887919581772DENTFLEX FIBER POST5013920U05013920U02022-12-01
08404535030853Brasseler USA5032379U05032379U02026-08-21
08404535030822Brasseler USA5032378U05032378U02026-07-13
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850001745628Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2022-08-22
00850001745635Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2022-08-22
M75240473APP0STRADIS HEALTHCARESTRADIS MEDICAL, LLCNYD2022-03-21
00850001745000Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
00850001745017Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
00085000174500Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
M75240473APP1STRADISSTRADIS MEDICAL, LLCNYD2016-05-05