FDA.reportPublic FDA data

BLACK & BLACK SURGICAL, INC.

Primary DI
00840329838225
Brand
BLACK & BLACK SURGICAL, INC.
Company
BLACK & BLACK SURGICAL, INC.
Model
B8XBAS-432BH-AH-RT
Catalog number
B8XBAS-432BH-AH-RT
Device description
BASKET PATTERN CANNULA; 4MM X 32CM BYRON HANDLE W/ASPIRATION HOLE W/ ROUNDED TIP
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113795000SUCTION LIPOLASTY ACCESSORIESNorman M. Black Iii2012-08-07QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329838225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329838225008403298382258403298382250840329838225

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B089B797250Fiberoptic Cable B79725B797252016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04260170881021Biofill Infiltration CannulaHuman Med AGQPB2025-07-30