FDA UDI In Commercial Distribution 🇺🇸 United States

Non-Woven Sponge

DI: 00616784336213 · Model: 3362 · DYNAREX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
2

Basic Information

Brand Name
Non-Woven Sponge
Primary DI
00616784336213
Version / Model
3362
Company Name
DYNAREX CORPORATION
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2021-06-21
Public Version
2
Public Version Date
2021-08-24
Public Version Status
Update
Public Device Record Key
133c5d8b-5689-4525-9b20-1f73902d3ac0

Device Description

Non-Woven Sponge, Sterile, 2's, 2"x2", 4ply

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
NAB Gauze / Sponge,Nonresorbable For External Use
FRL Fiber, Medical, Absorbent

GMDN Terms

Code Name
48131 Non-woven gauze pad

Identifiers

Type ID
Package 00616784336220
Primary 00616784336213
Package 00616784336237
Unit of Use 00616784336206