FDA UDI In Commercial Distribution 🇺🇸 United States

COVRSITE

DI: 00040565120249 · Model: 59715000 · SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
COVRSITE
Primary DI
00040565120249
Version / Model
59715000
Catalog Number
59715000
Company Name
SMITH & NEPHEW MEDICAL LIMITED
Labeler DUNS
216344051
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-19
Public Version
2
Public Version Date
2026-02-02
Public Version Status
Update
Public Device Record Key
8601fe5c-a96c-40ea-b77e-0fb7049c88ec

Device Description

CovRSite Plus Dressing 4 x 4 CTN10

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KGX Tape and bandage, adhesive

GMDN Terms

Code Name
46854 Wound-nonadherent dressing, absorbent, non-antimicrobial

Identifiers

Type ID
Package 00040565120256
Primary 00040565120249
Package 30040565120257

Customer Contacts

Device Sizes

Type Value Unit Text
Length 10 Centimeter
Width 10 Centimeter

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
25C / 77F
Type
Special Storage Condition, Specify
Special Conditions
Keep away from sunlight
Type
Special Storage Condition, Specify
Special Conditions
Keep dry