FDA.reportPublic FDA data

N/A

Primary DI
00840329800277
Brand
N/A
Company
BLACK & BLACK SURGICAL, INC.
Model
B89107
Catalog number
B89107
Device description
SILICONE CONNECTION TUBE WITH C-CLAMP AND LUER FITTING
Published
2022-09-21
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840329800277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840329800277008403298002778403298002770840329800277

GMDN Terms#

Term, Definition table
TermDefinition
Disposable vacuum tubingA sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use 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
true
Premarket exempt
true
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
00840329800291N/AB89109B891092022-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607151050627AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAPYX MEDICAL CORPORATIONQPB2026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAPYX MEDICAL CORPORATIONQPB2026-06-26
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