FDA.report

Avalign

Primary DI
00190776210786
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM88-4179
Device description
Liston Amputation Knife,
Published
2021-11-03
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
GDNKNIFE, AMPUTATION

Product Code Classifications

CodeDeviceSpecialtyClass
GDNKnife, AmputationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776210786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776210786001907762107861907762107860190776210786

GMDN Terms

TermDefinition
Amputation knifeA hand-held manual surgical instrument with a handle and a heavy single-edged or double-edged blade, of various shapes and sizes, used in surgery for the amputation of a limb. It is typically a one-piece instrument made of high-grade stainless steel. 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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