FDA.reportPublic FDA data

SMR STEMLESS

Primary DI
08033390100533
Brand
SMR STEMLESS
Company
LIMACORPORATE SPA
Model
9013.35.165
Catalog number
9013.35.165
Device description
SMR STEMLESS Shoulder - Humeral Head Adaptors Extractor
Published
2023-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390100533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390100533080333901005338033390100533

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
432066322
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
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16
10705034533681NADEPUY SPINE, LLCHWB2019-01-16
10705034533698NADEPUY SPINE, LLCHWB2019-01-16
10705034533704NADEPUY SPINE, LLCHWB2019-01-16
10705034533711NADEPUY SPINE, LLCHWB2019-01-16
10705034533728NADEPUY SPINE, LLCHWB2019-01-16
10705034533735NADEPUY SPINE, LLCHWB2019-01-16
10705034533742NADEPUY SPINE, LLCHWB2019-01-16
10705034534060NADEPUY SPINE, LLCHWB2019-01-16
10705034534152NADEPUY SPINE, LLCHWB2019-01-16
10705034534169NADEPUY SPINE, LLCHWB2019-01-16
10705034497754N/ADEPUY SPINE, LLCHWB2018-11-05
10603295080763NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087861NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087878NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090595GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090649GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295156017RECLAIMDEPUY (IRELAND)HWB2018-09-24
10603295159087LPSDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295171669S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171676S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171683S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295178408NADEPUY (IRELAND)HWB2018-09-24
10603295181651S-ROM NOILESDEPUY (IRELAND)HWB2018-09-24
10603295248439SPECIALISTDEPUY (IRELAND)HWB2018-09-24