AvaBoots 5.0

Primary DI
07898939912272
Brand
AvaBoots 5.0
Company
AVANUTRI EQUIPAMENTOS DE SAUDE LTDA
Model
GG
Published
2025-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IROVibrator, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IROVibrator, TherapeuticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898939912272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898939912272078989399122727898939912272

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898347861
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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00813859002619PretikaPRETIKA CORPORATIONIRO2019-07-01
B108714GUNALXC0BTL Cellutone handpieceBTL INDUSTRIES LIMITEDIRO2017-01-12
B108714GUNALXCENUS0BTL Cellutone handpieceBTL INDUSTRIES LIMITEDIRO2017-01-12
B108744POCTENUS0BTL CellutoneBTL INDUSTRIES LIMITEDIRO2017-01-12
07290103039004VSA-3000 Vibratory Sensory AnalazerMEDOC LTD.IRO2016-09-24
07290103039509VSA-3000 Vibratory Sensory AnalazerMEDOC LTD.IRO2016-09-24