| Primary Device ID | 00850025860161 |
| NIH Device Record Key | 271573eb-657b-442e-ae40-c51258d43472 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coloshield Procedure Drape |
| Version Model Number | COL-7055-50 |
| Company DUNS | 079873914 |
| Company Name | Micro-tech Usa |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850025860154 [Primary] |
| GS1 | 00850025860161 [Package] Contains: 00850025860154 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 00850025860178 [Package] Package: Case [4 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-11 |
| Device Publish Date | 2025-03-03 |
| 10850025860809 - Scope Tip Protector | 2025-03-19 Distal Tip Protector Small |
| 10850025860816 - Scope Tip Protector | 2025-03-19 Distal Tip Protector Large |
| 00850025860437 - Irrigation Tubing Set | 2025-03-17 Irrigation Tubing Set |
| 00858276007557 - Sterile Bacteriostatic Lubricating Gel | 2025-03-13 Sterile Bacteriostatic Lubricating Gel |
| 00850025860406 - Air/Water Bottle CO2 Tubing | 2025-03-12 Air/Water Bottle CO2 Tubing Olympus |
| 00850025860468 - Air/Water Bottle Tubing | 2025-03-12 Air/Water Bottle Tubing Olympus |
| 10850025860489 - Endoscopy Kit - Basic + Gowns | 2025-03-12 Endoscopy Kit - Basic + Gowns |
| 00850025860574 - 4-Piece Valve Kit | 2025-03-12 A/W Suction Valve Kit Lub Pen 4 Piece |