FDA.report

Avalign

Primary DI
00190776047733
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM104-1651
Device description
Maltz Rasp, downstroke
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
JYYRASP, EAR

Product Code Classifications

CodeDeviceSpecialtyClass
JYYRasp, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776047733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776047733001907760477331907760477330190776047733

GMDN Terms

TermDefinition
Nasal file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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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