FDA UDI In Commercial Distribution 🇺🇸 United States

Cypress

DI: 10815555021021 · Model: 35-10 · MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50

Basic Information

Brand Name
Cypress
Primary DI
10815555021021
Version / Model
35-10
Company Name
MCKESSON MEDICAL-SURGICAL INC.
Labeler DUNS
023904428
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2020-07-07
Public Version
2
Public Version Date
2021-04-07
Public Version Status
Update
Public Device Record Key
36bd9151-dff9-4f4b-8c23-549e1ff03149

Device Description

SHOE COVER, REG UNI-SIZE

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
Yes
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OEA Non-Surgical Isolation Gown

GMDN Terms

Code Name
15056 Shoe cover

Identifiers

Type ID
Package 20815555021028
Primary 10815555021021
Unit of Use 00815555024001