FDA.reportPublic FDA data

LSSS

Primary DI
05060433600807
Brand
LSSS
Company
Lockdown Medical Ltd
Model
RM04053
Catalog number
RM04053
Device description
"DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm. THE FINISHED PART NUMBER IS IN631/1 - ""DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm - RM04053"""
Published
2020-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
LXIGuide, Drill, Ligament
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060433600807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433600807050604336008075060433600807

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
211167885
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060433600326AC DEVICELDIN628/SLDIN628/S2017-02-23
05060433600845LSSSRM04953RM049532020-07-24
05060433600920LSSSRM06005RM060052020-07-24
05060433600005AC DEVICELD050LD0502015-10-30
05060433600012AC DEVICELD060LD0602015-10-30
05060433600029AC DEVICELD070LD0702015-10-30
05060433600036AC DEVICELD080LD0802015-10-30
05060433600043AC DEVICELD090LD0902015-10-30
05060433600050AC DEVICELD100LD1002015-10-30
05060433600067AC DEVICELD110LD1102015-10-30
05060433600074AC DEVICELD120LD1202015-10-30
05060433600081AC DEVICELD130LD1302015-10-30
05060433600098AC DEVICELD140LD1402015-10-30
05060433600104AC DEVICELD150LD1502015-10-30
05060433600111AC DEVICELD160LD1602015-10-30
05060433600128AC DEVICELD170LD1702015-10-30
05060433600135AC DEVICELD180LD1802015-10-30
05060433600142AC DEVICELD190LD1902015-10-30
05060433600159AC DEVICELD200LD2002015-10-30
05060433600166AC DEVICELDCW09LDCW092015-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
G453332321055BC010PEAK MEDICALPeak Medical Distribution Inc.LXI2026-05-06
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29