FDA UDI In Commercial Distribution 🇺🇸 United States

Ophthalmic Pledget

DI: 20749915002528 · Model: 111-01 · AMERICAN SURGICAL COMPANY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
Ophthalmic Pledget
Primary DI
20749915002528
Version / Model
111-01
Company Name
AMERICAN SURGICAL COMPANY, LLC
Labeler DUNS
151054954
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2018-10-17
Public Version
1
Public Version Date
2018-11-19
Public Version Status
New
Public Device Record Key
f503338b-a84b-4a43-8fbb-271434a5295d

Device Description

Ophthalmic Pledget

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
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
HOZ Sponge, Ophthalmic

GMDN Terms

Code Name
63282 Cotton wool ball, sterile

Identifiers

Type ID
Primary 20749915002528
Unit of Use 10749915002521