| Primary Device ID | 00893029002441 |
| NIH Device Record Key | 44302e8f-39a2-4023-a425-a3244f44f97d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPOT Endosopic Marker |
| Version Model Number | GIS-44 |
| Catalog Number | GIs-44 |
| Company DUNS | 160990313 |
| Company Name | GI Supply, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com | |
| Phone | 1-800-451-5797 |
| customer_service@gi-supply.com |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893029002069 [Primary] |
| GS1 | 00893029002441 [Package] Contains: 00893029002069 Package: 10 Count Canister [10 Units] In Commercial Distribution |
| NBG | Marker,Colon |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-17 |
| Device Publish Date | 2016-09-24 |
| 00893029002731 - RenovaRP | 2023-12-22 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 Set | 2022-08-18 RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the RenovaRP Paracentesis Management System to remov |
| 10893029002592 - MoonPants SM | 2021-07-28 MoonPants SM single-use non-sterile garment |
| 10893029002608 - MoonPants ML | 2021-07-28 MoonPants ML single-use non-sterile garment |
| 10893029002615 - MoonPants XL | 2021-07-28 MoonPants XL single-use non-sterile garment |
| 10893029002622 - MoonPants Long | 2021-07-28 MoonPants Long single-use non-sterile garment |
| 00893029002670 - SportShorts XS | 2021-07-28 SportShorts XS single-use non-sterile garment |
| 00893029002687 - SportShorts SM | 2021-07-28 SportShorts SM single-use non-sterile garment |