FDA.reportPublic FDA data

Tornier Perform

Primary DI
03700386973536
Brand
Tornier Perform
Company
TORNIER
Model
MWE101
Catalog number
MWE101
Device description
Keeled Punch
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
03700386973536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700386973536037003869735363700386973536

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03700386944871Aequalis™ Ascend™ FlexDWF615B2015-10-16
03700386944888Aequalis™ Ascend™ FlexDWF615C2015-10-16
03700386944895Aequalis™ Ascend™ FlexDWF616A2015-10-16
03700386944901Aequalis™ Ascend™ FlexDWF616B2015-10-16
03700386944918Aequalis™ Ascend™ FlexDWF616C2015-10-16
03700386944925Aequalis™ Ascend™ FlexDWF617A2015-10-16
03700386944932Aequalis™ Ascend™ FlexDWF617B2015-10-16
03700386944949Aequalis™ Ascend™ FlexDWF617C2015-10-16
03700386944956Aequalis™ Ascend™ FlexDWF618A2015-10-16
03700386944963Aequalis™ Ascend™ FlexDWF618B2015-10-16
03700386944970Aequalis™ Ascend™ FlexDWF618C2015-10-16
03700386945045Aequalis™ Ascend™ FlexDWF702A2015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08681506800251SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
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