FDA.reportPublic FDA data

LSSS

Primary DI
05060433600890
Brand
LSSS
Company
Lockdown Medical Ltd
Model
RM06010
Catalog number
RM06010
Device description
"DEPTH GAUGE OUTER BODY CAP. THIS CAP SCREWS ONTO ""DEPTH GAUGE OUTER BODY TUBE - RM06008 (DI NO# 05060433600906)"" AND ENCLOSES ""DEPTH GAUGE INNER BODY WITH BALL & SPRING - RM06009 (DI NO# 05060433600913)"". THIS CREATES THE FINAL INSTRUMENT IN626/1 - ""DEPTH GAUGE ASSEMBLY- AS01069 """
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
EILGauge, Depth, Instrument, Dental
HTJGauge, Depth
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1
HTJGauge, DepthOrthopedic1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060433600890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060433600890050604336008905060433600890

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
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00198506092428ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00840456202104JMUJMU DENTAL, INCMDM2026-07-27
00840456215760JMUJMU DENTAL, INCMDM2026-07-27