FDA.reportPublic FDA data

MyOstomy

Primary DI
00860010399705
Brand
MyOstomy
Company
Myostomy Distribution LLC
Model
G4772250
Device description
Ostomy Suction Device, 22.5mm
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
20860010399709PackageGS11In Commercial Distribution
00860010399705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086001039970920860010399709
00860010399705008600103997058600103997050860010399705

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.

Regulatory Flags#

DUNS number
120805657
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010399712MyOstomyG47725002023-09-14
20860010399709MyOstomyG47722502023-09-14
20860010399716MyOstomyG47725002023-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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