FDA.reportPublic FDA data

COTISEN

Primary DI
06954454000571
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
BB02
Device description
Bur holder box is mainly used to store different dental tools, such us burs, grinding heads etc.
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454000571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454000571069544540005716954454000571

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
06954454000465COTISENCD012026-10-28
06954454000472COTISENCD022026-10-28
06954454000489COTISENCD032026-10-28
06954454000564COTISENBB012026-10-28
06954454000588COTISENBB032026-10-28
06954454000595COTISENBF012026-10-28
06954454000601COTISENBC012026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337122104iLESSYS® Delta Access TrayJoimax GmbHFSM2026-10-28
04250337122111iLESSYS® Delta Resection TrayJoimax GmbHFSM2026-10-28
06954454000564COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000588COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000595COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000601COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001202COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001271COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
M739223000700Nav Instruments General TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739223000800Nav Instruments Pedicle Screws TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739253001012Discectomy Prep TrayCAPTIVA SPINE, INC.FSM2026-10-28
00889024702660OsseoFitZimmer, Inc.FSM2026-10-27
00889024702677OsseoFitZimmer, Inc.FSM2026-10-27
00889024702684OsseoFitZimmer, Inc.FSM2026-10-27
00889024702691OsseoFitZimmer, Inc.FSM2026-10-27
00889024702707OsseoFitZimmer, Inc.FSM2026-10-27
00889024702714OsseoFitZimmer, Inc.FSM2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMFBrainlab SEFSM2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)Brainlab SEFSM2026-10-27
04250337118497Vaporgrip® Bipo Sterilization TrayJoimax GmbHFSM2026-10-27
04250337119265TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
04250337119272TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699885IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699892IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699908IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699915Comprehensive HumeralZimmer, Inc.FSM2026-10-21
00889024699922Identity HumeralZimmer, Inc.FSM2026-10-21