FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919413943
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5001880U0
Device description
316 SCISSOR 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
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919413943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919413943008879194139438879194139430887919413943

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. 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
Lot or batch
true
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
G879103050TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103052SC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103062TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103065TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030900DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030920DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030930DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103107TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103113TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103116TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103118TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031230DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879GTC130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
B382SD903260120Surgical DirectSurgical Direct, Inc.EGN2026-09-29
G8791030490DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-08-23