FDA.report

SOFT PLUG® Extended Duration 180 Tapered Canalicular Plugs

Primary DI
10845819005993
Brand
SOFT PLUG® Extended Duration 180 Tapered Canalicular Plugs
Company
OASIS MEDICAL, INC.
Model
6210, 6210-A
Device description
SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug, 0.6mm
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LZUPlug, Punctum

Product Code Classifications

CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845819005990PackageGS120In Commercial Distribution
30845819005997PackageGS110In Commercial Distribution
10845819005993PrimaryGS10
00845819005996Unit of UseGS10

GMDN Terms

TermDefinition
Lacrimal punctum plugA sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
9093055400customerservice@oasismedical.com

Regulatory Flags

DUNS number
194121018
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00810061911944SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
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