FDA.reportPublic FDA data

COTISEN

Primary DI
06954454003916
Brand
COTISEN
Company
Huanghua Promisee Dental Co., Ltd.
Model
RD05
Device description
Forceps is used to place or remove clamps.
Published
2026-11-05
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
EMGForceps, Tooth Extractor, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954454003916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954454003916069544540039166954454003916

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954454002414COTISENRD012026-11-05
06954454002421COTISENRD022026-11-05
06954454002438COTISENRD032026-11-05
06954454002490COTISENPB01A2026-11-05
06954454002506COTISENPB01B2026-11-05
06954454002513COTISENPB01C2026-11-05
06954454002520COTISENPB02A2026-11-05
06954454002537COTISENPB02B2026-11-05
06954454002544COTISENPB02C2026-11-05
06954454002551COTISENPB03A2026-11-05
06954454002568COTISENPB03B2026-11-05
06954454002575COTISENPB03C2026-11-05
06954454003879COTISENRD092026-11-05
06954454003886COTISENRD112026-11-05
06954454003923COTISENRD062026-11-05
06954454004791COTISEN442026-11-05
06954454007037COTISENPC05M2026-11-05
06954454007112COTISENPC05F2026-11-05
06954454010730COTISENRD122026-11-05
06954454010747COTISEN552026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00083208131301DDP Extraction ForcepsSuncoast Dental, IncEMG2026-11-03
00083208132308DDP Extraction ForcepsSuncoast Dental, IncEMG2026-11-03
00850090726034Intrace USAPILOTIS TECH LLCEMG2026-10-31
00850090726041Intrace USAPILOTIS TECH LLCEMG2026-10-31
00850090726089Intrace USAPILOTIS TECH LLCEMG2026-10-31
00850090726232Intrace USAPILOTIS TECH LLCEMG2026-10-31
00850090726348Intrace USAPILOTIS TECH LLCEMG2026-10-31
B382SD936706060Surgical DirectSurgical Direct, Inc.EMG2026-10-20
G879100044A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMG2026-09-30
G879100049A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMG2026-09-30
D955ROWDISL1Paul BandittTerlain Enterprises, Inc.EMG2026-09-25
D955ROWDISR1Paul BandittTerlain Enterprises, Inc.EMG2026-09-25
00190776411084MillenniumAvalign Technologies, Inc.EMG2026-08-07
G879100001A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMG2026-07-31
00190776403676MillenniumAvalign Technologies, Inc.EMG2026-07-21
00190776403232MillenniumAvalign Technologies, Inc.EMG2026-07-19
00850083275556Intrace USAPILOTIS TECH LLCEMG2026-07-03
G149TBSB7010TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7020TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7030TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7040TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7050TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7060TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7070TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7080TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7090TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7100TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7110TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7120TBS BASICSACME ENTERPRISE.EMG2026-05-21
G149TBSB7130TBS BASICSACME ENTERPRISE.EMG2026-05-21