U.S. IOL, Inc. US-9002LZV

GUDID 00814106016137

9/0 Micro Spatula, Double-Armed PGA Suture

U.S. IOL, INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID00814106016137
NIH Device Record Key478d8095-69ab-40cc-b254-19a0e16475d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameU.S. IOL, Inc.
Version Model NumberUS-9002LZV
Catalog NumberUS-9002LZV
Company DUNS604739490
Company NameU.S. IOL, INC.
Device Count1
DM Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com
Phone+1(859)259-4925
Emailusiol@aol.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814106016120 [Primary]
GS100814106016137 [Package]
Contains: 00814106016120
Package: Box of 12 [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


[00814106016137]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-30
Device Publish Date2020-09-22

On-Brand Devices [U.S. IOL, Inc.]

008141060161518/0 Micro Spatula, Double-Armed Silk Suture
008141060161379/0 Micro Spatula, Double-Armed PGA Suture
008141060161138/0 Micro Spatula, Double-Armed PGA Suture
008141060160907/0 Micro Spatula, Double-Armed PGA Suture
008141060160766/0 Side Cutting Spatula, Double-Armed PGA Suture
0081410601605210/0 Micro Spatula, Double-Armed Nylon Suture
0081410601603810/0 Micro Spatula, Double-Armed Nylon Suture
008141060160149/0 Micro Spatula, Double-Armed Nylon Suture
008141060159948/0 Micro Spatula, Double-Armed Nylon Suture
008141060159707/0 Taper Point, Double-Armed Nylon Suture
008141060159566/0 Micro Spatula, Double-Armed Nylon Suture
00803878044721U-BLUE Trypan Blue Solution 0.06%

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.