FDA.reportPublic FDA data

Aztec

Primary DI
B87110181000
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-18100
Catalog number
10-18100
Device description
Day Ear Hook, Extra Small
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
JYLHook, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B87110181000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT probe, reusableA slender, rod-like, hand-held manual surgical instrument, typically with a blunt bulbous or pointed tip, used for exploring fistulas, cavities or wounds used during ear/nose/throat (ENT) intervention. The distal end of the instrument, before the bulb/point, may be bent at a right angle to the shaft. 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
04054462906680evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906697evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906703evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906710evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906727evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906734evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906765evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906772evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906796evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906826evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907069evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907113evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907274evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907335evonosevonos GmbH & Co. KGJYL2026-08-21
04054462911585evonosevonos GmbH & Co. KGJYL2026-08-19
04054462901524evonosevonos GmbH & Co. KGJYL2026-08-18
04054462901531evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18