FDA UDI In Commercial Distribution 🇺🇸 United States

OPSITE FLEXIFIX 10CMX10M

DI: 05000223411473 · Model: 66000041 · SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
OPSITE FLEXIFIX 10CMX10M
Primary DI
05000223411473
Version / Model
66000041
Catalog Number
66000041
Company Name
SMITH & NEPHEW MEDICAL LIMITED
Labeler DUNS
216344051
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-26
Public Version
2
Public Version Date
2023-09-07
Public Version Status
Update
Public Device Record Key
c52b8804-c4e9-499a-88c0-5a9627b96497

Device Description

Transparent film roll

Device Characteristics

Single Use
No
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
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
34832 Waterproof skin adhesive tape

Identifiers

Type ID
Package 05000223415143
Primary 05000223411473