FDA.report

Vilex

Primary DI
00190776295653
Brand
Vilex
Company
Avalign Technologies, Inc.
Model
RD-REAM-130
Device description
13.0mm Flexible Reamer Head
Published
2023-11-14
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
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776295653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776295653001907762956531907762956530190776295653

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, flexibleAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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