FDA.reportPublic FDA data

Blunt Tip Microcannula Slim Fabinject 25G38MM

Primary DI
07898915128604
Brand
Blunt Tip Microcannula Slim Fabinject 25G38MM
Company
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA
Model
BTC25G038BX10 BR
Device description
Blunt Tip Microcannula Slim Fabinject 25G 38 mm, single use sterile pack with pilot needle - box with 10 units
Published
2025-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898915128604PrimaryGS10
07898493080561Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898915128604078989151286047898915128604
07898493080561078984930805617898493080561

GMDN Terms#

Term, Definition table
TermDefinition
Tissue injection cannulaA thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(321) 972-4528contact@fabinject.com

Regulatory Flags#

DUNS number
902645407
Device count
10
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
07898493080073Skin Cooler Roller - LARGE (white)SCRLARGEWHITEBX012024-06-14
07898493080080Skin Cooler Roller - LARGE (lilac)SCRLARGELILACBX012024-06-14
07898493080097Skin Cooler Roller - LARGE (blue)SCRLARGEBLUEBX012024-06-14
07898493080103Skin Cooler Roller - LARGE (green)SCRLARGEGREENBX012024-06-14
07898493080110Skin Cooler Roller - SMALL (white) SCRSMALLWHITEBX012024-06-13
07898493080127Skin Cooler Roller - SMALL (lilac)SCRSMALLLILACBX012024-06-14
07898493080134Skin Cooler Roller - SMALL (blue)SCRSMALLBLUEBX012024-06-14
07898493080141Skin Cooler Roller - SMALL (green)SCRSMALLGREENBX012024-06-14
07898915128352Skin Cooler PenSCPBX012024-06-13
07898915128598Blunt Tip Microcannula Slim Fabinject 18G70MMBTC18G070BX10 BR2025-06-03
07898915128628Blunt Tip Microcannula Slim Fabinject 27G38MMBTC27G038BX10 BR2025-06-03
07898915128789VF1000LED Vein locatorVF1000LEDBX12024-06-07

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