FDA UDI In Commercial Distribution 🇺🇸 United States

ESI

DI: B3961501820 · Model: 15-0182 · FTT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ESI
Primary DI
B3961501820
Version / Model
15-0182
Company Name
FTT MEDICAL, INC.
Labeler DUNS
002212793
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
4
Public Version Date
2023-11-17
Public Version Status
Update
Public Device Record Key
5bbb56e9-60c3-4027-99b4-22295d89c457

Device Description

HIRSCHMAN ANOSCOPE, MEDIUM, 3/4" X 2-3/4". ACMI FITTING.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
FER Anoscope And Accessories

GMDN Terms

Code Name
10156 Optical anoscope, reusable

Identifiers

Type ID
Primary B3961501820