FDA UDI In Commercial Distribution 🇺🇸 United States

Hemostat Gauze Dressing

DI: 00616784368719 · Model: 3687 · DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1

Basic Information

Brand Name
Hemostat Gauze Dressing
Primary DI
00616784368719
Version / Model
3687
Company Name
DYNAREX CORPORATION
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-21
Public Version
1
Public Version Date
2021-06-29
Public Version Status
New
Public Device Record Key
b094628f-8f05-40a9-a1e1-db01cc17e909

Device Description

Hemostat Gauze Dressing, 4"x4"

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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FRO Dressing, Wound, Drug

GMDN Terms

Code Name
64869 Plant polysaccharide/inorganic composite haemostatic agent

Identifiers

Type ID
Package 00616784368726
Primary 00616784368719
Package 00616784368733
Package 00616784368740