FDA.report

SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long

Primary DI
10845819000233
Brand
SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long
Company
OASIS MEDICAL, INC.
Model
6403, 6403-A
Device description
SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long, 2 plugs per pouch
Published
2022-09-07
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

Contact Domains

Product Codes

CodeName
LZUPlug, Punctum

Product Code Classifications

CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845819000230PackageGS120In Commercial Distribution
30845819000237PackageGS110In Commercial Distribution
10845819000233PrimaryGS10
00845819000236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084581900023020845819000230
3084581900023730845819000237
1084581900023310845819000233
00845819000236008458190002368458190002360845819000236

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.

Device Sizes

TypeValueUnit
Length2Millimeter
Outer Diameter0.3Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
909-305-5400customerservice@oasismedical.com

Regulatory Flags

DUNS number
194121018
Device count
2
DM exempt
false
Premarket exempt
false
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
false

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