FDA UDI In Commercial Distribution 🇺🇸 United States

Sheathes

DI: 10842418102467 · Model: 26339VCI · SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
Sheathes
Primary DI
10842418102467
Version / Model
26339VCI
Company Name
SHEATHING TECHNOLOGIES, INC.
Labeler DUNS
806806220
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2018-05-25
Public Version
1
Public Version Date
2018-06-25
Public Version Status
New
Public Device Record Key
671215d7-1f62-4c93-9936-216f081eee52

Device Description

Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long, Vital Care Industries Custom Label

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ITX Transducer, Ultrasonic, Diagnostic

GMDN Terms

Code Name
60609 Body-orifice ultrasound imaging transducer cover, basic, non-sterile

Identifiers

Type ID
Package 20842418102464
Primary 10842418102467
Unit of Use 00842418102170