FDA.reportPublic FDA data

Aztec

Primary DI
B87111152000
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
11-15200
Catalog number
11-15200
Device description
Klinik Ear Cup Forcep 2mm round
Published
2020-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B87111152000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

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

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Primary DI, Brand, Company table
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G043201200BEARBear-Ent, LLCGEN2026-04-17
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