FDA.reportPublic FDA data

ENDOTRAC

Primary DI
07613327356182
Brand
ENDOTRAC
Company
Stryker GmbH
Model
2040
Catalog number
2040
Device description
Synovial Elevator
Published
2017-05-30
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
HRXARTHROSCOPE
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327356182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327356182076133273561827613327356182

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
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
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345721204Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721211Surgical Manual InstrumentMedacta International SANBH2026-03-30
07630345721228Surgical Manual InstrumentMedacta International SANBH2026-03-30
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
07630345778765Sports Med InstrumentsMedacta International SANBH2023-01-16
07630542702457Sports Med InstrumentsMedacta International SANBH2023-01-16
07613327379624NASTRYKER CORPORATIONNBH2022-12-06
07613327554663OmnicurveSTRYKER CORPORATIONHRX2022-04-12
07613327554687OmnicurveSTRYKER CORPORATIONHRX2022-04-12
07613327554700OmnicurveSTRYKER CORPORATIONHRX2022-04-12
07613327562750SDC4KSTRYKER CORPORATIONHRX2022-04-04
07613327053067NASTRYKER CORPORATIONNBH2021-09-09
07630040723855Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040723886Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040723893Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040723930Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040723947Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040723954Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040723961Sports Med InstrumentsMedacta International SANBH2020-12-09
07630040724494Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212718Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212725Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212756Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212763Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212770Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212787Sports Med InstrumentsMedacta International SANBH2020-12-09
07630971212794Sports Med InstrumentsMedacta International SANBH2020-12-09