FDA.reportPublic FDA data

Blunt Tip Microcannula Slim Fabinject 20G100MM

Primary DI
00850064466034
Brand
Blunt Tip Microcannula Slim Fabinject 20G100MM
Company
FABINJECT LLC
Model
BTC20G100UOU
Device description
Blunt Tip Microcannula Slim Fabinject 20G100MM single unit packaged in sterile blister pack
Published
2024-08-13
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

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
00850064466034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064466034008500644660348500644660340850064466034

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
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(321)972-4528fabinjectllc_regulatory@outlook.com

Regulatory Flags#

DUNS number
032329574
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
00850064466027FREDDO120 v2024-10-28
00850064466379Skin Cooler Roller - SMALL (lilac)SCRSMALLLILACBX012025-03-04
00850064466386Skin Cooler Roller - SMALL (blue)SCRSMALLBLUEBX012025-03-04
00850064466393Skin Cooler Roller - SMALL (green)SCRSMALLGREENBX012025-03-04
00850064466409Skin Cooler Roller - LARGE (white)SCRLARGEWHITEBX012025-03-04
00850064466416Skin Cooler Roller - LARGE (lilac)SCRLARGELILACBX012025-03-04
00850064466423Skin Cooler Roller - LARGE (blue)SCRLARGEBLUEBX012025-03-04
00850064466430Skin Cooler Roller - LARGE (green)SCRLARGEGREENBX012025-03-04
00850064466355Skin Cooler PenSCPBX012025-03-02
00850064466362Skin Cooler Roller - SMALL (white)SCRSMALLWHITEBX012025-03-04
00850064466188Blunt Tip Microcannula Slim Fabinject 22G50MMBTC22G050BX102025-02-28
00850064466348VF1000LED Vein locatorVF1000LEDBX12025-03-02
00850064466249Duck-bill Tip Microcannula Slim Fabinject 15G100MMDBC15G100BX102024-08-14
00850064466256Duck-bill Tip Microcannula Slim Fabinject 20G70MMDBC20G070BX102024-08-14
00850064466041Blunt Tip Microcannula Slim Fabinject 21G50MM BTC21G050UOU2024-08-13
00850064466058Blunt Tip Microcannula Slim Fabinject 21G70MMBTC21G070UOU2024-08-13
00850064466065Blunt Tip Microcannula Slim Fabinject 22G50MM BTC22G050UOU2024-08-13
00850064466072Blunt Tip Microcannula Slim Fabinject 22G70MMBTC22G070UOU2024-08-13
00850064466126Duck-bill Tip Microcannula Slim Fabinject 15G100MMDBC15G100UOU2024-08-13
00850064466133Duck-bill Tip Microcannula Slim Fabinject 20G70MM DBC20G070UOU2024-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810128462799StayPort™ Cannula 5 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
B382SD2303290Surgical DirectSurgical Direct, Inc.GEA2026-07-14
B382SD303490Surgical DirectSurgical Direct, Inc.GEA2026-07-14
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20192253036821MonojectCardinal Health 200, LLCGEA2026-07-09
00850083275709Intrace USAPILOTIS TECH LLCGEA2026-07-03
00810130456550Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00810130456567Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456482Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456505Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05