FDA.report

Aequalis Reversed II

Primary DI
03700386972010
Brand
Aequalis Reversed II
Company
TORNIER
Model
MWD148
Catalog number
MWD148
Device description
GLENOID SPHERE EXTRACTOR SCREW
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

Related Records

Contact Domains

Product Codes

CodeName
HWBEXTRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700386972010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700386972010037003869720103700386972010

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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

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