FDA.reportPublic FDA data

DENALI

Primary DI
00810042120488
Brand
DENALI
Company
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Model
MUA4-410
Device description
Perry Tweezer - Curved Tip
Published
2020-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCXEpilator, High Frequency, Tweezer-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCXEpilator, High Frequency, Tweezer-TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042120488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042120488008100421204888100421204880810042120488

GMDN Terms#

Term, Definition table
TermDefinition
Dental dressing forceps, reusableA hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
077801124
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042124875OSE8007-7772026-01-28
00810042124844OSEX009-0062025-11-26
00810042124851OSEX009-0072025-11-26
00810042124868OSEX009-0082025-11-26
00869843000239Depend-On0169-0002016-07-29
00869843000277OSE0167-0002016-07-29
00869843000291OSE 8oz. Orthodontic Etching Gel - Blue240M-L002018-06-13
00810042124745OSE0202-0072023-08-11
00810042124752OSE0202-0082023-08-11
00810042124769OSE0202-0092023-08-11
00810042124738OSE0580-0122023-07-20
00810042124547OSE0202-F2023-06-21
00810042124554OSE0202-G2023-06-21
00810042124561OSE0202-H2023-06-21
00810042124578OSE0202-J2023-06-21
00810042124585OSE0202-K2023-06-21
00810042124592OSE0202-W2023-06-21
00810042124608OSE0202-Y2023-06-21
00810042124639OSE0202-N2023-06-21
00810042124646OSE0202-P2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974456210518CICADAFoshan Cicada Dental Instrument Co., Ltd.KCX2024-08-10
G443CSC2311Bracket Tweezer with SlotCHURAHI SURGICAL CO.KCX2023-08-08
G443CSC2321Bracket Tweezer Tube HoldingCHURAHI SURGICAL CO.KCX2023-08-08
G443CSC2331Bracket Tweezer small PointCHURAHI SURGICAL CO.KCX2023-08-08
00810072350831TweezersCole Instruments IncKCX2021-12-14
00810042120464DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120471DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120235DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120242DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120259DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120266DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
00810042120273DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCKCX2020-04-21
07898961579146IbramedIbramed Industria Brasileira de Equipamentos Medicos EirKCX2017-10-13