FDA.reportPublic FDA data

VOLMED BRASIL

Primary DI
07908783000176
Brand
VOLMED BRASIL
Company
VOLMED BRASIL EQUIPAMENTOS LTDA
Model
AAGU03
Device description
SUTURE NEEDLE - COMP. WITH SCORPION II
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
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908783000176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908783000176079087830001767908783000176

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, single-useA cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use 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
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
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
16931918121994AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-04-06
16931918157016AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
16931918179858AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
16931918144948AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27
10192253052312DevonCardinal Health 200, LLCGAB2025-03-27
10192253052336DevonCardinal Health 200, LLCGAB2025-03-27
10192253052343DevonCardinal Health 200, LLCGAB2025-03-27
10192253052350DevonCardinal Health 200, LLCGAB2025-03-27
10192253052367DevonCardinal Health 200, LLCGAB2025-03-27
10192253052374DevonCardinal Health 200, LLCGAB2025-03-27
10192253052381DevonCardinal Health 200, LLCGAB2025-03-27
10192253053357DevonCardinal Health 200, LLCGAB2025-03-27