FDA.reportPublic FDA data

LPS

Primary DI
10603295159155
Brand
LPS
Company
DEPUY (IRELAND)
Model
2987-72-040
Catalog number
298772040
Device description
LPS SLAP HANDLE
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZYHAMMER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295159155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329515915510603295159155

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093937ELMED INCORPORATEDELMED INCORPORATEDFZY2026-08-18
00824846000907Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FZY2026-08-16
09348811083098INKAThe Trustee for KAISER FAMILY TRUSTFZY2026-07-31
03701089527866AMPLITUDEAMPLITUDE SASFZY2026-07-29
10705034647616N/AMedos International SàrlFZY2026-07-09
00198506091179ELMED INCORPORATEDELMED INCORPORATEDFZY2026-06-03
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
00810189451483Surgical DesignSurgical Design, Inc.FZY2026-05-23
00198506089114ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
00198506089411ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
10705034579023N/AMedos International SàrlFZY2026-03-05
00840493416472LUX Expandable Interbody SystemXENIX MEDICAL LLCFZY2026-02-24
03662663083638ActivLHighridge Medical, LLCFZY2026-02-03
03662663083645ActivLHighridge Medical, LLCFZY2026-02-03
03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
03662663083669ActivLHighridge Medical, LLCFZY2026-02-03
03662663083676ActivLHighridge Medical, LLCFZY2026-02-03
03662663083690ActivLHighridge Medical, LLCFZY2026-02-03
03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155762Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155779Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663244695Vital MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-12-18
04262494463150N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463174N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463167N/ADoppkon GmbH & Co. KGFZY2025-11-28
03662663216951Telluride MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-11-17
03662663267205Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663267601Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663279123Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
00196449034604Anatomic Access LLIFTyber Medical, LLCFZY2025-10-22