FDA.reportPublic FDA data

N/A

Primary DI
B089B8XSPA2715L0
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B8XSPA-2.715L
Catalog number
B8XSPA-2.715L
Device description
SPATULA CANNULA, 2.7MM X 15CM LARGE HANDLE
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B089B8XSPA2715L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, reusableA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(770)414-4880info@blackandblacksurgical.com

Regulatory Flags#

DUNS number
004382282
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329811518N/AB79808B798082022-09-21
00840329811525N/AB79809B798092022-09-21
B089B784600Headlight CableB78460B784602016-07-29
B089B784640Headlight CableB78464B784642016-07-29
B089B797180Fiberoptic Cable B79718B797182016-07-29
B089B797190Fiberoptic Cable B79719B797192016-07-29
B089B797220Fiberoptic Cable B79722B797222016-07-29
B089B797230Fiberoptic Cable B79723B797232016-07-29
B089B797240Fiberoptic Cable B79724B797242016-07-29
B089B797250Fiberoptic Cable B79725B797252016-07-29
B089B797260Fiberoptic Cable B79726B797262016-07-29
B089B797270Fiberoptic Cable B79727B797272016-07-29
B089B797280Fiberoptic Cable B79728B797282016-07-29
B089B797590Fiberoptic Cable B79759B797592016-07-29
B089B797600Fiberoptic Cable B79760B797602016-07-29
B089B797610Fiberoptic Cable B79761B797612016-07-29
B089B797650Fiberoptic Cable B79765B797652016-07-29
B089B797660Fiberoptic Cable B79766B797662016-07-29
B089B797670Fiberoptic Cable B79767B797672016-07-29
B089B797680Fiberoptic Cable B79768B797682016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456413Medco ManufacturingMedco Manufacturing LLCGEA2026-06-02
00846338005436Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007324Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007331Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007348Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007355Working PortELLIQUENCE, LLCGEA2026-06-02
00846338007362Working PortELLIQUENCE, LLCGEA2026-06-02
00846338005535Suction TubeELLIQUENCE, LLCGEA2026-06-01
00846338005542Suction TubeELLIQUENCE, LLCGEA2026-06-01
00810130456390Medco ManufacturingMedco Manufacturing LLCGEA2026-05-29
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13
G589DS25G501DermaSculptCosmoFranceGEA2026-04-13
G589DS27G251DermaSculptCosmoFranceGEA2026-04-13
G589DS27G401DermaSculptCosmoFranceGEA2026-04-13
G589DS27G501DermaSculptCosmoFranceGEA2026-04-13
G589DS30G251DermaSculptCosmoFranceGEA2026-04-13
10192253037906MonojectCardinal Health 200, LLCGEA2026-04-07
10192253037913MonojectCardinal Health 200, LLCGEA2025-10-10
10669808004008SoftFil® EasyGuideProllenium MedicalGEA2025-08-28
10669808004084SoftFil® PrecisionProllenium MedicalGEA2025-08-28
10192253003444ArgyleCardinal Health 200, LLCGEA2024-10-09
10192253003451ArgyleCardinal Health 200, LLCGEA2024-10-09
10850013527028DannikDannik LLCGEA2023-01-21
10850013527073DannikDannik LLCGEA2023-01-21