FDA.reportPublic FDA data

Tornier Perform

Primary DI
03700386973888
Brand
Tornier Perform
Company
TORNIER
Model
MWE152
Catalog number
MWE152
Device description
CANNULATED DRILL/REAMER DRIVER WITH TIP
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFGBIT, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700386973888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700386973888037003869738883700386973888

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+330476613500order@tornier.com

Regulatory Flags#

DUNS number
260324876
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700386968303Aequalis FractureMWA302MWA3022022-08-08
03700386915260AEQUALISDWB1512015-10-16
03700386916144AEQUALIS REVERSEDDWB9352015-10-16
03700386916151AEQUALIS REVERSEDDWB9362015-10-16
03700386916618AEQUALIS REVERSEDDWD0022015-10-16
03700386916731AEQUALIS REVERSEDDWD0692015-10-16
03700386931529AEQUALIS REVERSED ADAPTERDWD8632015-10-16
03700386931536AEQUALIS REVERSED ADAPTERDWD8642015-10-16
03700386931543AEQUALIS REVERSED ADAPTERDWD8652015-10-16
03700386925726BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0212017-04-03
03700386955648BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0032016-09-11
03700386955655BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0042017-04-03
03700386915062AEQUALIS GLENOIDDWB0012016-01-28
03700386915079AEQUALIS GLENOIDDWB0022015-10-16
03700386915086AEQUALIS GLENOIDDWB0032015-10-16
03700386915093AEQUALIS GLENOIDDWB0052015-10-16
03700386915109AEQUALIS GLENOIDDWB0062015-10-16
03700386915413AEQUALIS GLENOIDDWB2102015-10-16
03700386915420AEQUALIS GLENOIDDWB2112015-10-16
03700386915437AEQUALIS GLENOIDDWB2122015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888277354029MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354074MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
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10888277355057MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
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10888277378278MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
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10080196393152MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
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10888277336971MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
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10888277355439MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
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10888277374478MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277377196MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29