FDA.reportPublic FDA data

Smart Lock

Primary DI
08800080230029
Brand
Smart Lock
Company
BSL Co.,Ltd
Model
PLK-003
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800080230029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800080230029088000802300298800080230029

GMDN Terms#

Term, Definition table
TermDefinition
Syringe lockA small device designed to attach between the thumb rest of a syringe plunger and the top of the syringe barrel to lock the syringe in an open position to eliminate the need to manually hold the syringe plunger when generating a vacuum within the syringe. It is typically made of stainless steel and is available for different size syringes (e.g., 60 cc, 30 cc, 10 cc versions). It is typically used for the collection of adipose tissue from the patient or a container holding the tissue or other substances from plastic and reconstructive surgery, cosmetic surgery, or general surgery procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82513289235bsl@biosl.com

Regulatory Flags#

DUNS number
694860273
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
08800080200053Smart kit BasicSKT-0212023-05-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400477MillenniumAvalign Technologies, Inc.MDM2026-07-17
00198506092367ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-17
00198506092374ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-17
00198506092381ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-17
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29