FDA.reportPublic FDA data

LSSS

Primary DI
05060433600876
Brand
LSSS
Company
Lockdown Medical Ltd
Model
RM06006
Catalog number
RM06006
Device description
"AO CANNULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING. THE ""AO SCREWDRIVER SPINNER"" - DI NO# (05060433600883) SCREWS ONTO THE END OF THIS DEVICE. THIS CREATES THE FINAL INSTRUMENT IN630/1 - ""AO CANNULATED HANDLE WITH QUICK COUPLING AND SPINNER - AS01068"" "
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
HXXScrewdriver
LRZScrewdriver, Surgical
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060433600876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433600876050604336008765060433600876

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
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03701089541022AMPLITUDEAMPLITUDE SASHXX2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
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00198506092039ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27