Primary Device ID | B4247203000C1 |
NIH Device Record Key | c662fbb6-38f5-4869-8e60-a7ff2a15bf02 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Speculum Rectal |
Version Model Number | SPO1 Large Straight Speculum |
Catalog Number | 720300C1 |
Company DUNS | 942667882 |
Company Name | CLEARWATER COLON HYDROTHERAPY, INC. |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
B4247201000C1 - Speculum, Rectal | 2018-10-22 Speculum, Rectal Straight Style Small ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720 |
B4247202000C1 - Speculum, Rectal | 2018-10-22 Speculum, Rectal Bulb Style Small ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720200C |
B4247203000C1 - Speculum Rectal | 2018-10-22Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720300C1 (Class I Device |
B4247203000C1 - Speculum Rectal | 2018-10-22 Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720 |
B4247204000C1 - Speculum, Rectal | 2018-10-22 Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720400C |
B424921442 - Colonic Irrigation Kit | 2018-10-22 Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, California Proposition 65 Material |
B424921448 - Colonic Irrigation Kit | 2018-10-22 Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, California Proposition 65 Material |
B424921478C1 - Speculum, Rectal Kit | 2018-10-22 Speculum, Rectal Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, Califor |
B424921648 - Speculum, Rectal Kit | 2018-10-22 Speculum, Rectal Straight Style Small Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, Califor |