FDA.reportPublic FDA data

Aztec

Primary DI
B87110804000
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-80400
Catalog number
10-80400
Device description
Iris Scissor, Super cut with black handles, curved serrated tips
Published
2020-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B87110804000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435479MillenniumAvalign Technologies, Inc.LRW2026-10-20
00190776436629MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776436728MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776439712MilleniumAvalign Technologies, Inc.LRW2026-10-20
B356111PL87514ST0steriSTATAmerican MedicalsLRW2026-10-20
00190776435325MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435332MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435400MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435189MillenniumAvalign Technologies, Inc.LRW2026-10-16
00190776434915MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435042MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435059MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435066MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435073MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776434649MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776434793MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776433864MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436278MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436292MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776433635MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434403MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434496MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434502MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434519MillenniumAvalign Technologies, Inc.LRW2026-10-07
G141510457190Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-10-07
00190776433987MillenniumAvalign Technologies, Inc.LRW2026-10-06
00190776433994MillenniumAvalign Technologies, Inc.LRW2026-10-06
10841767100537Trinity Sterile, Inc.Trinity Sterile, Inc.LRW2026-10-06
00190776435882MillenniumAvalign Technologies, Inc.LRW2026-09-30
04059453158284Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-30