FDA.reportPublic FDA data

BEAR

Primary DI
B351B699010
Brand
BEAR
Company
Mytamed, Inc.
Model
6.99.01
Catalog number
6.99.01
Device description
Snare Wire, Ear, 12 Pack
Published
2020-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JZDSnare, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZDSnare, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351B699010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015903922
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B351BMLGA4X6AC0BEARMLGA4X6ACMLGA4X6AC2021-02-09
B351BMLGA4X6ST0BEARMLGA4X6STMLGA4X6ST2021-02-09
B351BMLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2021-02-09
B351BMLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2021-02-09
B351BMLGO4X6AC0BEARMLGO4X6ACMLGO4X6AC2021-02-09
B351BMLGO4X6ST0BEARMLGO4X6STMLGO4X6ST2021-02-09
B351BMLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2021-02-09
B351BMLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2021-02-09
B351BMLGS4X6AC0BEARMLGS4X6ACMLGS4X6AC2021-02-09
B351BMLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7AC0mytaMedMLGA4X7ACMLGA4X7AC2021-02-09
B351MLGO4X7AC0mytaMedMLGO4X7ACMLGO4X7AC2021-02-09
B351MLGO4X7ST0mytaMedMLGO4X7STMLGO4X7ST2021-02-09
B351MLGS4X7AC0mytaMedMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7ST0mytaMedMLGA4X7STMLGA4X7ST2020-12-14
B351BMLGS4X6ST0BEARMLGS4X6STMLGS4X6ST2020-05-13
B351BMLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2020-05-13
B351MLGS4X7ST0mytaMedMLGS4X7STMLGS4X7ST2020-05-13
B351MLGA4X6AC0mytaMedMLGA4X6ACMLGA4X6AC2018-02-16
B351MLGA4X6ST0mytaMedMLGA4X6STMLGA4X6ST2018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20757770457650Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
20757770457667Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
20757770457674Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
00757770412914Bausch + LombBausch & Lomb IncorporatedJZD2025-08-04
00842962145937HNM MedicalHNM STAINLESS, LLC.JZD2024-03-08
00888515231061BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00888515231085BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00190776221171AvalignAvalign Technologies, Inc.JZD2023-06-23
00842331189456Novo Surgical Inc. NOVO SURGICAL, INC.JZD2022-11-14
00190660173708Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173715Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173722Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
04046826102272MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826102289MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826102296MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826334963MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826334987MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826334994MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826102258MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826317539MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826102241MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826317522MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826317546MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276126MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276140MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
04046826276157MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZD2020-09-24
B351B699000BEARMytamed, Inc.JZD2020-08-20
04038653176359AESCULAPAesculap AGJZD2020-04-22
04038653176342AESCULAPAesculap AGJZD2020-04-22
04038653341269AESCULAPAesculap AGJZD2020-04-22