Speculum Rectal 720300C1

GUDID B4247203000C1

Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720300C1 (Class I Device

CLEARWATER COLON HYDROTHERAPY, INC.

Colonic lavage kit, non-surgical Colonic lavage kit, non-surgical
Primary Device IDB4247203000C1
NIH Device Record Keyc662fbb6-38f5-4869-8e60-a7ff2a15bf02
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeculum Rectal
Version Model NumberSPO1 Large Straight Speculum
Catalog Number720300C1
Company DUNS942667882
Company NameCLEARWATER COLON HYDROTHERAPY, INC.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone352-401-0303
Emailsales@colonhydrotherapy.com
Phone352-401-0303
Emailsales@colonhydrotherapy.com

Device Dimensions

Length6 Inch
Length6 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Stored in Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored in Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB4247203000C1 [Package]
Contains: B424720300C1
Package: Plastic Bag [1 Units]
In Commercial Distribution
HIBCCB424720300C1 [Primary]

FDA Product Code

FFQSpeculum, Rectal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-22
Device Publish Date2017-09-05

Devices Manufactured by CLEARWATER COLON HYDROTHERAPY, INC.

B4247201000C1 - Speculum, Rectal2018-10-22 Speculum, Rectal Straight Style Small ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720
B4247202000C1 - Speculum, Rectal2018-10-22 Speculum, Rectal Bulb Style Small ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720200C
B4247203000C1 - Speculum Rectal2018-10-22Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720300C1 (Class I Device
B4247203000C1 - Speculum Rectal2018-10-22 Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720
B4247204000C1 - Speculum, Rectal2018-10-22 Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720400C
B424921442 - Colonic Irrigation Kit2018-10-22 Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, California Proposition 65 Material
B424921448 - Colonic Irrigation Kit2018-10-22 Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, California Proposition 65 Material
B424921478C1 - Speculum, Rectal Kit2018-10-22 Speculum, Rectal Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, Califor
B424921648 - Speculum, Rectal Kit2018-10-22 Speculum, Rectal Straight Style Small Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, Califor

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