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
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28