FDA.reportPublic FDA data

BLACK & BLACK SURGICAL, INC.

Primary DI
00840329834142
Brand
BLACK & BLACK SURGICAL, INC.
Company
BLACK & BLACK SURGICAL, INC.
Model
B86025
Catalog number
B86025
Device description
AIRSCULPT ASPIRATOR; DUAL MOTOR
Published
2024-04-15
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
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329834142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329834142008403298341428403298341420840329834142

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004382282
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840329838225BLACK & BLACK SURGICAL, INC.B8XBAS-432BH-AH-RTB8XBAS-432BH-AH-RT2026-06-08
00840329838232BLACK & BLACK SURGICAL, INC.B8XIII-332BH-AH-RTB8XIII-332BH-AH-RT2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.B8XIII-432BH-AH-RTB8XIII-432BH-AH-RT2026-06-08
00840329805982N/AB61115B611152022-09-21
00840329806033N/AB61126B611262022-09-21
00840329813369N/AB61112-ALB61112-AL2022-09-21
00840329813376N/AB61112SB61112S2022-09-21
00840329813512N/AB61120SB61120S2022-09-21
00840329837365BLACK & BLACK SURGICAL, INC.B89LL1.2B89LL1.22026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.B89LL1.4B89LL1.42026-05-04
00840329802592N/AB54790B547902022-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30
04260170880505WAL applicatorHuman Med AGQPB2025-07-30
04260170880826WAL CannulaHuman Med AGQPB2025-07-30
04260170880864WAL CannulaHuman Med AGQPB2025-07-30
04260170880888WAL CannulaHuman Med AGQPB2025-07-30
04260170880901WAL CannulaHuman Med AGQPB2025-07-30
04260170880925WAL CannulaHuman Med AGQPB2025-07-30
04260170880949WAL CannulaHuman Med AGQPB2025-07-30
04260170880963WAL CannulaHuman Med AGQPB2025-07-30
04260170881007Biofill CannulaHuman Med AGQPB2025-07-30