FDA.reportPublic FDA data

Smart kit Basic

Primary DI
08800080200053
Brand
Smart kit Basic
Company
BSL Co.,Ltd
Model
SKT-021
Published
2023-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKLLipoaspirate Washing System For Aesthetic Body Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKLLipoaspirate Washing System For Aesthetic Body ContouringGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2207220

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2207220

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800080200053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800080200053088000802000538800080200053

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/injection setA collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82553289235bsl@biosl.com

Regulatory Flags#

DUNS number
694860273
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800080220013ACS Combo-A CentrifugeACS-1012025-11-12
08800080211011Smart SyringeSKT-SS-1002023-05-11
08800080260019ATPU(Automatic Tissue Processing unit)ACPU-1002023-05-11
08800080200015Smart kit BasicSKT-0102023-05-11
08800080200022Smart kit BasicSKT-0202023-05-11
08800080200039Smart kit BasicSKT-0602023-05-11
08800080200046Smart kit BasicSKT-0112023-05-11
08800080200060Smart kit BasicSKT-0612023-05-11
08800080201012Smart kit ProSKT-140602023-05-11
08800080201029Smart kit ProSKT-240602023-05-11
08800080201036Smart kit ProSKT-124402023-05-11
08800080201043Smart kit ProSKT-224402023-05-11
08800080201050Smart kit ProSKT-12460 2023-05-11
08800080201067Smart kit ProSKT-224602023-05-11
08800080202019AdinizerSKT-AN-1002023-05-11
08800080202026AdinizerSKT-AN-2002023-05-11
08800080202033AdinizerSKT-AN-4002023-05-11
08800080202040AdinizerSKT-AN-6002023-05-11
08800080202057AdinizerSKT-AN-12002023-05-11
08800080202064AdinizerSKT-AN-24002023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08681877009017Lipocube NanoSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009086Centrifgue Container (15CC)STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009093Centrifgue Container (20 CC) STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009116Lipocube HybridSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009345Lipocube Hybrid ISTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009826Lipocube Hybrid MiniSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
00850034511047Puregraft SYNCBimini Technologies LLCQKL2026-02-24
04260170881083FillerCollectorHuman Med AGQKL2025-07-30
04260170881373Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881403Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
04260170881410Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
04260170881427Extraction cannula, LCHuman Med AGQKL2025-07-30
04260170881434Extraction cannulaHuman Med AGQKL2025-07-30
04260170881441Extraction cannulaHuman Med AGQKL2025-07-30
04260170881502Extraction tubeHuman Med AGQKL2025-07-30
04260170881571FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
04260170881076FillerCollectorHuman Med AGQKL2025-07-30
04260170881366FillerCollectorHuman Med AGQKL2025-07-30
14260170881370Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881380LipoCollector 3, completeHuman Med AGQKL2025-07-30
14260170881400Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
14260170881417Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
14260170881424Extraction cannula, LCHuman Med AGQKL2025-07-30
14260170881431Extraction cannulaHuman Med AGQKL2025-07-30
14260170881448Extraction cannulaHuman Med AGQKL2025-07-30
14260170881509Extraction tubeHuman Med AGQKL2025-07-30
14260170881578FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
00860005496709SyntrFuge SystemSyntr Health Technologies, IncQKL2024-10-17
00860005496723SyntrFuge System 30Syntr Health Technologies, IncQKL2024-10-17
00850034511023Puregraft 850 System Twin PackBimini Technologies LLCQKL2024-08-22