SUMMIT MEDICAL 3003

GUDID 00810061911937

ACCUFLO, STERILE, X-LARGE

KRISHNA IMPORTS INC

Lacrimal punctum plug
Primary Device ID00810061911937
NIH Device Record Key10d3c428-339a-44e0-9c6f-63e870da0e54
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUMMIT MEDICAL
Version Model Number3003
Catalog Number3003
Company DUNS081853285
Company NameKRISHNA IMPORTS INC
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com
Phone8592594925
Emailinfo@stephensinst.com

Device Dimensions

Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter
Outer Diameter1.02 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810061911265 [Primary]
GS100810061911937 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZUPlug, Punctum

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


[00810061911937]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

On-Brand Devices [SUMMIT MEDICAL]

00810061911937ACCUFLO, STERILE, X-LARGE
00810061911920ACCUFLO, STERILE, LARGE
00810061911913ACCUFLO, STERILE, MEDIUM
00810061911982ACCUFLO, STERILE, SMALL
00810061911975COMFORT TIP, STERILE, LARGE
00810061911968COMFORT TIP, STERILE, MEDIUM
00810061911951COMFORT TIP, STERILE, SMALL
00810061911944COMFORT TIP, STERILE, X-SMALL

Trademark Results [SUMMIT MEDICAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SUMMIT MEDICAL
SUMMIT MEDICAL
76311856 3043090 Live/Registered
SUMMIT MEDICAL LIMITED
2001-09-12
SUMMIT MEDICAL
SUMMIT MEDICAL
74676630 2038183 Dead/Cancelled
Summit Medical Systems, Inc.
1995-05-16

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