FDA.report

mytaMed

Primary DI
B351738010
Brand
mytaMed
Company
Mytamed, Inc.
Model
7.38.01
Catalog number
7.38.01
Device description
Bowman Lacrymal Probe, SS, 0000/000
Published
2018-02-16
Public version status
Update
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
HTEElevator

Product Code Classifications

CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B351738010PrimaryHIBCC0

GMDN Terms

TermDefinition
Lacrimal probe, reusableA hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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

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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

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M93072015342S20Life InstrumentsLife Instrument CorporationHTE2026-03-06
M93072015342SF20Life InstrumentsLife Instrument CorporationHTE2026-03-06
00840277133373Innomed, Inc.INNOMED, INC.HTE2026-02-26
00840277133380Innomed, Inc.INNOMED, INC.HTE2026-02-26
00190776416539MillenniumAvalign Technologies, Inc.HTE2026-02-16
03662663109468Mergence-A Preparation InstrumentationHighridge Medical, LLCHTE2026-02-11
00190376539003Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTE2026-02-10
M93072513543B0Life Instruments Life Instrument CorporationHTE2026-02-02
00840180545096General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840180545102General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840180545119General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840277133151Innomed, Inc.INNOMED, INC.HTE2026-01-16
00840180543313General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543320General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543337General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543344General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543351General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543368General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
03662663156905SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHTE2025-12-29
00199150051687Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051694Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051700Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
03662663272186Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272193Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272209Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272216Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272223Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18