FDA.reportPublic FDA data

PHYSICA

Primary DI
08033390110549
Brand
PHYSICA
Company
LIMACORPORATE SPA
Model
9065.95.150
Catalog number
9065.95.150
Device description
PHYSICA - Patellar Caliper
Published
2023-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390110549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390110549080333901105498033390110549

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. 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
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18