FDA UDI In Commercial Distribution 🇺🇸 United States

mytaMed

DI: B351MV27700 · Model: mV-2770 · Mytamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
mytaMed
Primary DI
B351MV27700
Version / Model
mV-2770
Catalog Number
mV-2770
Company Name
Mytamed, Inc.
Labeler DUNS
015903922
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2023-11-17
Public Version Status
Update
Public Device Record Key
07cad7a1-5cca-4f8b-8393-8ba0d5acf329

Device Description

mytaView ac Rigid ENT Endoscope, 2.7 x 140mm, 70 degree

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["High-level Disinfectant", "Peracetic Acid", "Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
EOB Nasopharyngoscope (Flexible Or Rigid)

GMDN Terms

Code Name
37180 Rigid optical sinoscope

Identifiers

Type ID
Primary B351MV27700

Premarket Submissions

Submission Number Supplement Number
K981751 000