FDA.report

Avalign

Primary DI
00190776044268
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM101-4452
Device description
Middle Ear Mirror, Angled
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
FTXMIRROR, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
FTXMirror, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776044268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776044268001907760442681907760442680190776044268

GMDN Terms

TermDefinition
General/plastic surgery mirrorA reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.

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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00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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