FDA.reportPublic FDA data

Clearwand

Primary DI
00860009877801
Brand
Clearwand
Company
MORRIS MEDICAL, INC.
Model
CW1000
Device description
Rectal Cleansing System
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHFSystem, Evacuator, Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHFSystem, Evacuator, FluidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009877818PackageGS15In Commercial Distribution
00860009877801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009877818008600098778188600098778180860009877818
00860009877801008600098778018600098778010860009877801

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Regulatory Flags#

DUNS number
111194428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009877818ClearwandCW10002024-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009877818ClearwandMORRIS MEDICAL, INC.FHF2024-10-22
00607915146498Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
00607915146504Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
03700512902102RocaFlow Laparoscopy TubingPromeplaFHF2020-08-27
03700512912101RocaFlow Endoscopy TubingPromeplaFHF2020-08-27
03700512902034Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512902041Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512902058Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512902065Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512902072Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512902089Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512922032Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512922049Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512922056Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512922063Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512922070Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512922087Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512901976Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
03700512921974Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
06939029815187SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
26939029815181SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
06939029815163MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
06939029815170MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815167MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815174MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
03700512901839Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512901860Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512921837Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512921868Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512901815Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spikePromeplaFHF2017-11-09