FDA.reportPublic FDA data

Aztec

Primary DI
B8711055400
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-5540
Device description
Roch Pean Hemostatic Forcep, Straight
Published
2022-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAEForceps, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8711055400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
B382SD9196141000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9196141010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421020Surgical DirectSurgical Direct, Inc.KAE2026-07-29
00190776405908MillenniumAvalign Technologies, Inc.KAE2026-07-26
00190776404147MillenniumAvalign Technologies, Inc.KAE2026-07-24
00190776403874MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403911MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403782MillenniumAvalign Technologies, Inc.KAE2026-07-21
04046826110833MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-07-21
00190776402198MillenniumAvalign Technologies, Inc.KAE2026-07-19
00190776395353MillenniumAvalign Technologies, Inc.KAE2026-07-14
00850083275785Intrace USAPILOTIS TECH LLCKAE2026-07-03
00850083275860Intrace USAPILOTIS TECH LLCKAE2026-07-03
04054462923465evonosevonos GmbH & Co. KGKAE2026-06-26
00810220800294Adler Instrument CompanyAdler, Inc.KAE2026-06-02
09348811022066INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-06-02
09348811105417INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-05-29
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12