FDA UDI In Commercial Distribution 🇺🇸 United States

Quintess Tear Pool

DI: 00850048647213 · Model: 20-5305 · El Paso Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Quintess Tear Pool
Primary DI
00850048647213
Version / Model
20-5305
Company Name
El Paso Medical, LLC
Labeler DUNS
131183053
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-11
Public Version
1
Public Version Date
2023-08-21
Public Version Status
New
Public Device Record Key
dc4c1316-6eb9-44ec-8464-bc2a43dc36eb

Device Description

Quintess Tear Pool Kit, 0.5 mm PDO plugs mounted in an insertion tool, sterile.

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
No
MRI Safety
Labeling does not contain MRI Safety Information
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
LZU Plug, Punctum

GMDN Terms

Code Name
36237 Lacrimal punctum plug

Identifiers

Type ID
Primary 00850048647213
Package 10850048647210