FDA.reportPublic FDA data

Aztec

Primary DI
B87110144040
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-14404
Catalog number
10-14404
Device description
Lawson Suction Elevator-Gorney
Published
2020-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B87110144040PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
117559084
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B87110221000Aztec10-2210010-221002020-10-06
B87110221010Aztec10-2210110-221012020-10-06
B87110221020Aztec10-2210210-221022020-10-06
B87110221030Aztec10-2210310-221032020-10-06
B87110221040Aztec10-2210410-221042020-10-06
B87110221050Aztec10-2210510-221052020-10-06
B87110243570Aztec10-2435710-243572020-10-07
B87110243620Aztec10-2436210-243622020-10-07
B87110244000Aztec10-2440010-244002020-10-07
B87110244140Aztec10-2441410-244142020-10-07
B87110250000Aztec10-2500010-250002020-10-07
B87110251100Aztec10-2511010-251102020-10-07
B87110251110Aztec10-2511110-251112020-10-07
B87110243500Aztec10-2435010-243502020-10-06
B87110243520Aztec10-2435210-243522020-10-06
B87110243560Aztec10-2435610-243562020-10-06
B87111242000Aztec11-2420011-242002020-10-09
B87111242010Aztec11-2420111-242012020-10-09
B87111242020Aztec11-2420211-242022020-10-09
B87111245000Aztec11-2450011-245002020-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04054462907403evonosevonos GmbH & Co. KGKAD2026-08-18