FDA.reportPublic FDA data

VOLMED BRASIL

Primary DI
07908783000084
Brand
VOLMED BRASIL
Company
VOLMED BRASIL EQUIPAMENTOS LTDA
Model
A6411-ID
Device description
IRRIGATION SET - AR
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908783000084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908783000084079087830000847908783000084

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
903156736
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07908783000008VOLMED BRASILAEQU052025-03-06
07908783000015VOLMED BRASILAEQU102025-03-06
07908783000022VOLMED BRASIL41-01-06-002025-03-06
07908783000039VOLMED BRASILA450-100-ID2025-03-06
07908783000046VOLMED BRASILA10K100-ID2025-03-06
07908783000053VOLMED BRASILAEQU10-EX2025-03-06
07908783000060VOLMED BRASILAEQU112025-03-06
07908783000077VOLMED BRASILPPUS9M2025-03-06
07908783000091VOLMED BRASIL19-03-06-002025-03-06
07908783000107VOLMED BRASIL41-01-07-002025-03-06
07908783000114VOLMED BRASIL2739.1101-O2025-03-06
07908783000121VOLMED BRASIL2739.1101-P2025-03-06
07908783000138VOLMED BRASILA350-806-ID2025-03-06
07908783000145VOLMED BRASIL2739.CD.1103-P2025-03-06
07908783000152VOLMED BRASIL2739.CF.1106-E2025-03-06
07908783000169VOLMED BRASIL23-00-00-002025-03-06
07908783000176VOLMED BRASILAAGU032025-03-06
07908783000183VOLMED BRASILPPUS2M2025-03-06
07908783000190VOLMED BRASILPPUSN7N2025-03-06
07908783000206VOLMED BRASIL22-00-00-002025-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776431136MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776431143MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776427160MillenniumAvalign Technologies, Inc.NBH2026-08-21
00190776427177MillenniumAvalign Technologies, Inc.NBH2026-08-21
00198506094170ELMED INCORPORATEDELMED INCORPORATEDNBH2026-08-18
07630345716743SportsMed InstrumentsMedacta International SANBH2026-08-17
07630345716750SportsMed InstrumentsMedacta International SANBH2026-08-17
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28