SPOT Endosopic Marker GIs-44

GUDID 00893029002441

GI Supply, Inc.

Tissue marking ink
Primary Device ID00893029002441
NIH Device Record Key44302e8f-39a2-4023-a425-a3244f44f97d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPOT Endosopic Marker
Version Model NumberGIS-44
Catalog NumberGIs-44
Company DUNS160990313
Company NameGI Supply, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com
Phone1-800-451-5797
Emailcustomer_service@gi-supply.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100893029002069 [Primary]
GS100893029002441 [Package]
Contains: 00893029002069
Package: 10 Count Canister [10 Units]
In Commercial Distribution

FDA Product Code

NBGMarker,Colon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-17
Device Publish Date2016-09-24

Devices Manufactured by GI Supply, Inc.

00893029002731 - RenovaRP2023-12-22 The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Ba
10893029002165 - RenovaRP Tube Set2022-08-18 RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remov
10893029002592 - MoonPants SM2021-07-28 MoonPants SM single-use non-sterile garment
10893029002608 - MoonPants ML2021-07-28 MoonPants ML single-use non-sterile garment
10893029002615 - MoonPants XL2021-07-28 MoonPants XL single-use non-sterile garment
10893029002622 - MoonPants Long2021-07-28 MoonPants Long single-use non-sterile garment
00893029002670 - SportShorts XS2021-07-28 SportShorts XS single-use non-sterile garment
00893029002687 - SportShorts SM2021-07-28 SportShorts SM single-use non-sterile garment

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