FDA.reportPublic FDA data

SIGMA LCS HIGH PERFORMANCE

Primary DI
10603295227311
Brand
SIGMA LCS HIGH PERFORMANCE
Company
DEPUY ORTHOPAEDICS, INC.
Model
9505-02-011
Catalog number
950502011
Device description
SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH CEMENTED SIZE 2-3
Published
2018-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRYPUNCH, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295227311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329522731110603295227311

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. 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
080506581
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
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04063574200203nexoderm® Biopsy Punch Ø 2,0 mmsfm medical devices GmbHLRY2026-09-21
B382SD441309197120Surgical DirectSurgical Direct, Inc.LRY2026-08-03
03701089526586AMPLITUDEAMPLITUDE SASLRY2026-07-29
03701089527187AMPLITUDEAMPLITUDE SASLRY2026-07-29
03701089527194AMPLITUDEAMPLITUDE SASLRY2026-07-29
B382SD323690Surgical DirectSurgical Direct, Inc.LRY2026-07-28
B382SD323790Surgical DirectSurgical Direct, Inc.LRY2026-07-28
B8035903160ORTHOMEDORTHO-MED, INC.LRY2026-07-22
B8034800100ORTHOMEDORTHO-MED, INC.LRY2026-07-14
04946329039580Kerrison Rongeur 150 x 2 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039597Kerrison Rongeur 150 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039603Kerrison Rongeur 150 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039610Kerrison Rongeur 150 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039627Kerrison Rongeur 180 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039634Kerrison Rongeur 180 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039641Kerrison Rongeur 180 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039658Kerrison Rongeur 180 x 1 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
00846338005801KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005818KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005825KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005832KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005849KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005856KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005870KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005887KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005894KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005900KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005924KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005931KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005948KerrisonELLIQUENCE, LLCLRY2026-06-02