FDA.reportPublic FDA data

Blunt Tip Microcannula Slim Fabinject 22G50MM

Primary DI
00850064466188
Brand
Blunt Tip Microcannula Slim Fabinject 22G50MM
Company
FABINJECT LLC
Model
BTC22G050BX10
Device description
Blunt Tip Microcannula Slim Fabinject 22G 50 mm, single use sterile pack with pilot needle - box with 10 units
Published
2025-02-28
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
00850064466188PrimaryGS10
10850064466185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064466188008500644661888500644661880850064466188
1085006446618510850064466185

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
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
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
00850064466348VF1000LED Vein locatorVF1000LEDBX12025-03-02
00850064466249Duck-bill Tip Microcannula Slim Fabinject 15G100MMDBC15G100BX102024-08-14
00850064466256Duck-bill Tip Microcannula Slim Fabinject 20G70MMDBC20G070BX102024-08-14
00850064466034Blunt Tip Microcannula Slim Fabinject 20G100MMBTC20G100UOU2024-08-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407506MillenniumAvalign Technologies, Inc.GEA2026-07-31
00840329838409BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838416BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838430BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838454BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00840329838515BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-07-30
00810130456710Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456727Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456734Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
00810130456741Medco ManufacturingMedco Manufacturing LLCGEA2026-07-23
03661219357063DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
03661219357070DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
03661219357087DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
03661219357094DELACROIX-CHEVALIERLANDANGERGEA2026-07-23
00190776403812MillenniumAvalign Technologies, Inc.GEA2026-07-21
00190776403249MillenniumAvalign Technologies, Inc.GEA2026-07-19
00810220800485Adler Instrument CompanyAdler, Inc.GEA2026-07-17
10810128462782StayPort™ Cannula 5 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
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
00810130456574Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456581Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456598Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09