FDA.reportPublic FDA data

EZ SCULPT

Primary DI
00860009682191
Brand
EZ SCULPT
Company
Jordan Consulting Group, LLC
Model
EZ-2005
Device description
EZ Sculpt Disp. Microcannula, 27x1 1/2 (27x38mm)
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00860009941441PackageGS14In Commercial Distribution
00860009962941PackageGS120In Commercial Distribution
00860009682191PrimaryGS10
00860009941496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009941441008600099414418600099414410860009941441
00860009962941008600099629418600099629410860009962941
00860009682191008600096821918600096821910860009682191
00860009941496008600099414968600099414960860009941496

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.

Contacts#

Phone, Email table
PhoneEmail
786-547-8166sergio@medlife.us

Regulatory Flags#

DUNS number
080664909
Device count
25
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009682153EZ SCULPTEZ-20012023-02-24
00860009682160EZ SCULPTEZ-20022023-02-24
00860009682177EZ SCULPTEZ-20032023-02-24
00860009682184EZ SCULPTEZ-20042023-02-24
00860009962903EZ SCULPTEZ-20012023-02-24
00860009962910EZ SCULPTEZ-20022023-02-24
00860009962927EZ SCULPTEZ-20032023-02-24
00860009962934EZ SCULPTEZ-20042023-02-24
00860009962941EZ SCULPTEZ-20052023-02-24
00860009616509MedlifeX-SMALL2022-12-20
00860009616516MedlifeSMALL2022-12-20
00860009616523MedlifeMEDIUM2022-12-20
00860009616530MedlifeLARGE2022-12-20
00860009616547MedlifeX-LARGE2022-12-20

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