FDA.reportPublic FDA data

MyOstomy

Primary DI
20860010399716
Brand
MyOstomy
Company
Myostomy Distribution LLC
Model
G4772500
Device description
Ostomy Suction Device, 25mm
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860010399716PackageGS175In Commercial Distribution
00860010399712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086001039971620860010399716
00860010399712008600103997128600103997120860010399712

GMDN Terms#

Term, Definition table
TermDefinition
Cupping therapy deviceA dome typically made of glass or hard plastic intended to be used to manually produce sites of suction on the surface of the skin, or other soft tissues, in the practice of cupping therapy used by acupuncture and traditional Chinese medicine practitioners for localized healing or energy flow. The device is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120805657
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010399705MyOstomyG47722502023-09-14
00860010399712MyOstomyG47725002023-09-14
20860010399709MyOstomyG47722502023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206050haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
00848530106973Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106980Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106997Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107000Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107017Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106966Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107185Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-12
00848530106164Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106171Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106188Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106201Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106218Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106225Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106232Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106256Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106263Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106270Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530104467Suction KitSunset Healthcare Solutions, Inc.GCY2025-04-14