FDA UDI Not in Commercial Distribution 🇺🇸 United States

DEMATOCOPE HIGH RESOLUTION

DI: B1623021 · Model: BTS-302 · BELLEGROVE MEDICAL SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DEMATOCOPE HIGH RESOLUTION
Primary DI
B1623021
Version / Model
BTS-302
Catalog Number
FEDMEDMICFIP6M_US
Company Name
BELLEGROVE MEDICAL SUPPLY, INC.
Labeler DUNS
141647094
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-09-27
Public Version
2
Public Version Date
2022-09-30
Public Version Status
Update
Public Device Record Key
d255a1b6-d425-49e4-9358-5c1b68bffaee
Distribution End Date
2022-09-30

Device Description

DEMATOCOPE HIGH RESOLUTION

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ERA Otoscope

GMDN Terms

Code Name
12849 Otoscope, direct

Identifiers

Type ID
Primary B1623021