FDA UDI In Commercial Distribution 🇺🇸 United States

Sheathes

DI: 10842418102917 · Model: 5-246NS · SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25

Basic Information

Brand Name
Sheathes
Primary DI
10842418102917
Version / Model
5-246NS
Company Name
SHEATHING TECHNOLOGIES, INC.
Labeler DUNS
806806220
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2018-07-27
Public Version
1
Public Version Date
2018-08-27
Public Version Status
New
Public Device Record Key
da5efca6-c873-4a53-9cdc-161561582f21

Device Description

Polyurethane, 6"W x 24"L, Non-Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Rolled

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
OIP Radiology-Diagnostic Kit

GMDN Terms

Code Name
44713 Body-surface ultrasound imaging transducer cover

Identifiers

Type ID
Package 20842418102914
Primary 10842418102917
Unit of Use 00842418102910