FDA.reportPublic FDA data

COTISEN

Primary DI
06954454000465
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
CD01
Device description
Cotton Roll Dispenser is used to store small cotton rolls or balls.
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454000465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454000465069544540004656954454000465

GMDN Terms#

Term, Definition table
TermDefinition
Dressing dispenserA freestanding container with an opening designed to hold and dispense dressings (including swabs and bandages) in discrete quantities (e.g., one at a time) at the point of use. It is typically a plastic or metal container with a lid to allow loading of the dressings, and a separate port to allow easy retrieval of the dressings. It is used in settings such as an examination room, a doctor's surgery, or where surgical procedures are performed in the hospital. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1443-221-3031usa@medpath.pro

Regulatory Flags#

DUNS number
529444628
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954454000069COTISENHP022026-10-28
06954454000076COTISENHP032026-10-28
06954454000083COTISENHP042026-10-28
06954454000090COTISENHP052026-10-28
06954454000106COTISENHP062026-10-28
06954454000113COTISENHP072026-10-28
06954454000373COTISENDB012026-10-28
06954454000380COTISENDB022026-10-28
06954454000397COTISENDB032026-10-28
06954454000403COTISENDB042026-10-28
06954454000410COTISENDB052026-10-28
06954454000434COTISENDB072026-10-28
06954454000441COTISENDB062026-10-28
06954454000472COTISENCD022026-10-28
06954454000489COTISENCD032026-10-28
06954454000564COTISENBB012026-10-28
06954454000571COTISENBB022026-10-28
06954454000588COTISENBB032026-10-28
06954454000595COTISENBF012026-10-28
06954454000601COTISENBC012026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000472COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454000489COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454001196COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
06954454002131COTISENHuanghua Promisee Dental Co., Ltd.IKX2026-10-28
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00689281037419Wave Grab Bar, 18" Length, Left and Right, Polished Chrome (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281038065Wave Grab Bar, 1.25x18" Length, Matte BlackHealthcraft Products Inc.IKX2026-10-13
00689281038072Wave Grab Bar, 1.25x18" Length, Brushed StainlessHealthcraft Products Inc.IKX2026-10-13
00689281038089Wave Grab Bar, 1.25x18" Length, Brushed GoldHealthcraft Products Inc.IKX2026-10-13
00689281038096Wave Grab Bar, 1.25x18" Length, Polished ChromeHealthcraft Products Inc.IKX2026-10-13
00689281038348Wave Grab Bar, 18" Length, Left and Right, Brushed Gold (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281039413Wave Grab Bar, 1.25x18" Length, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-10-13
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00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledHealthcraft Products Inc.IKX2026-09-30