FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919408963
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5001341U0
Device description
ART PAPER FORCEP 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

Product Codes#

Code, Name table
CodeName
EFKFORCEPS, ARTICULATION PAPER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFKForceps, Articulation PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919408963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919408963008879194089638879194089630887919408963

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4290TBS BASICSACME ENTERPRISE.EFK2026-05-21
00889813066553Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFK2024-11-30
00813677022486PDT, Inc.PDT, INC.EFK2024-07-01
00842517103924Karl SchumacherKarl Schumacher Dental, LLCEFK2024-02-27
08800075603579OSUNG MNDOSUNG MND Co., Ltd.EFK2024-02-19
08964003163488NivoB. Ali ImpexEFK2024-01-29
08964003163662PREHMAB. Ali ImpexEFK2024-01-29
00310866002590NANOBYTEPASCAL COMPANY, INC.EFK2023-11-29
D040603000Forceps- PaperWHIP-MIX CORPORATIONEFK2023-08-18
07898506812141QuinelatoSchobell Industrial LtdaEFK2022-12-08
EZPF22100150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
EZPF22101150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
04963931270668NAYDM CORPORATIONEFK2022-09-30
04963931270675NAYDM CORPORATIONEFK2022-09-30
D77370010500Health-Tec/DHP Hand InstrumentsDental Health Products IncEFK2022-09-28
00850043381174Buffalo Dental MfgBuffalo Dental Manufacturing Co., Inc.EFK2022-08-05
00366975051059BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
00366975051066BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
G1577083000PomeePOMEE CORPORATIONEFK2022-01-04
G1577083050PomeePOMEE CORPORATIONEFK2022-01-04
G1577083100PomeePOMEE CORPORATIONEFK2022-01-04
D701ARPH2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D701ARPS2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D72310296083Safco Articulating Paper ForcepsSAFCO DENTAL SUPPLY CO.EFK2021-07-01
00840105217466ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217473ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217503ZOLL-DENTALZoll-DentalEFK2021-03-10
10889950004323HU-FRIEDYHU-FRIEDY MFG. CO., LLCEFK2020-11-12
10889950041489HU-FRIEDYHU-FRIEDY MFG. CO., LLCEFK2020-11-12
04560218667120DENTECHDENTECH CORPORATIONEFK2020-09-24