FDA.report

mytaMed

Primary DI
B351656090
Brand
mytaMed
Company
Mytamed, Inc.
Model
6.56.09
Catalog number
6.56.09
Device description
Rosen Ear Needle, Blunt Tip, Light Curve
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JYTPick, Microsurgical Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B351656090PrimaryHIBCC0

GMDN Terms

TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
015903922
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B351B203020BEAR2.03.022.03.022020-06-10
B351B615050BEAR6.15.056.15.052020-06-10
B351B620120BEAR6.20.126.20.122020-05-28
B351B620130BEAR6.20.136.20.132020-05-28
B351B620140BEAR6.20.146.20.142020-05-28
B351B706270BEAR7.06.277.06.272020-05-12
B351B706280BEAR7.06.287.06.282020-05-12
B351B706290BEAR7.06.297.06.292020-05-12
B351B706300BEAR7.06.307.06.302020-05-12
B351B706310BEAR7.06.317.06.312020-05-12
B351B706320BEAR7.06.327.06.322020-05-12
B351B706340BEAR7.06.347.06.342020-05-12
B351B707260BEAR7.07.267.07.262020-05-12
B351B810100BEAR8.10.108.10.102020-05-19
B351B707270BEAR7.07.277.07.272020-05-12
B351B707290BEAR7.07.297.07.292020-05-12
B351B707300BEAR7.07.307.07.302020-05-12
B351B810050BEAR8.10.058.10.052020-05-19
B351B810060BEAR8.10.068.10.062020-05-19
B351B810070BEAR8.10.078.10.072020-05-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09348811111906INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811150288INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
09348811150356INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
00757770682539Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
00757770714049Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
09348811112040INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-12-02
00757770688531Bausch + LombBausch & Lomb IncorporatedJYT2025-11-14
00757770406821Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
00757770407613Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
00757770404346Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770405725Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770407644Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770407774Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770413157Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770414628Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770416158Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770417025Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770417681Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770418190Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770424856Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770425273Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770433520Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770435425Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770435883Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770436613Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770436651Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00194613021733MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01
00194613021825MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01
00194613021832MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01