FDA.reportPublic FDA data

Avalign

Primary DI
00190776224042
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-1542
Device description
Rogers Elevator, curved,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KADELEVATOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776224042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776224042001907762240421907762240420190776224042

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776433017Millennium1-3201222026-10-01
00190776433024Millennium1-5255712026-10-01
00190776433031Millennium72-52832404M2026-10-01
00190776433048Millennium1-3201042026-10-01
00190776433055Millennium1-7752SD2026-10-01
00190776433062Millennium72-31940512026-10-01
00190776433079Millennium72-317910012026-10-01
00190776433086Millennium72-180526NR2026-10-01
00190776433093Millennium72-4220812026-10-01
00190776433109Millennium1-3202132026-10-01
00190776433116Millennium1-2051362026-10-01
00190776433123Millennium72-23011WS2026-10-01
00190776433130Millennium72-2411004CM2026-10-01
00190776433147Millennium72-2411003CM2026-10-01
00190776433154Millennium72-5242002H2026-10-01
00190776433161Millennium72-5242003H2026-10-01
00190776433178Millennium72-2414002026-10-01
00190776433185Millennium92-H0498R2026-10-01
00190776432911Millennium72-2430130452026-09-30
00190776432928Millennium72-5225522B42026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G2231337690Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKAD2026-10-01
00724995270704V. MuellerSTERIS Deutschland GmbHKAD2026-09-25
00724995270759V. MuellerSTERIS Deutschland GmbHKAD2026-09-25
04054462905577evonosevonos GmbH & Co. KGKAD2026-08-21
04054462905584evonosevonos GmbH & Co. KGKAD2026-08-21
04054462905645evonosevonos GmbH & Co. KGKAD2026-08-21
04054462906512evonosevonos GmbH & Co. KGKAD2026-08-21
04054462906529evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907366evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907380evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907397evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907441evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907496evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907502evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907519evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907526evonosevonos GmbH & Co. KGKAD2026-08-21
04054462911462evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911479evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911486evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911493evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911936evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911943evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911950evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911967evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911998evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912001evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912018evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912032evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912674evonosevonos GmbH & Co. KGKAD2026-08-19
04054462907373evonosevonos GmbH & Co. KGKAD2026-08-18