FDA UDI In Commercial Distribution 🇺🇸 United States

McKesson

DI: 10612479280868 · Model: 16-910S · MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
McKesson
Primary DI
10612479280868
Version / Model
16-910S
Company Name
MCKESSON MEDICAL-SURGICAL INC.
Labeler DUNS
023904428
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-11
Public Version
1
Public Version Date
2025-12-19
Public Version Status
New
Public Device Record Key
c8bbc514-8ba7-40fd-af8b-a42e997bb346

Device Description

DRESSING, POST OP SLVR HYDRCOLD 3.5X4

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Unsafe
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FRO Dressing, Wound, Drug

GMDN Terms

Code Name
47474 Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Identifiers

Type ID
Package 20612479280872
Primary 10612479280868
Package 40612479280883

Premarket Submissions

Submission Number Supplement Number
K180634 000