FDA UDI In Commercial Distribution 🇺🇸 United States

3005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects

DI: B9703005E1250 · Model: 3005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects · Tekscan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects
Primary DI
B9703005E1250
Version / Model
3005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects
Catalog Number
3005E-125
Company Name
Tekscan, Inc.
Labeler DUNS
178180246
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-03
Public Version
2
Public Version Date
2020-11-19
Public Version Status
Update
Public Device Record Key
576a353d-aa4c-436d-a5c0-cf5394eb2200

Device Description

3005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects one pair)

Device Characteristics

Single Use
Yes
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
No

Product Codes

Code Name
JFC System, Pressure Measurement, Intermittent

GMDN Terms

Code Name
43829 Body-surface pressure mapping system

Identifiers

Type ID
Primary B9703005E1250