FDA.reportPublic FDA data

VOLMED BRASIL

Primary DI
07908783000183
Brand
VOLMED BRASIL
Company
VOLMED BRASIL EQUIPAMENTOS LTDA
Model
PPUS2M
Device description
VOLMED PIEZO TIP MOD US2 M
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
07908783000183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908783000183079087830001837908783000183

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

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
07908783000084VOLMED BRASILA6411-ID2025-03-06
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
07908783000190VOLMED BRASILPPUSN7N2025-03-06
07908783000206VOLMED BRASIL22-00-00-002025-03-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
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