FDA.reportPublic FDA data

CENTURION

Primary DI
10653160316411
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
I68705
Catalog number
I68705
Device description
STERILE #5 DENTAL MIRROR 6.5"-(DM5)
Published
2022-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160316414PackageGS120In Commercial Distribution
10653160316411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160316414006531603164146531603164140653160316414
1065316031641110653160316411

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
017246562
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
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
10653160286479CENTURIONI68400I684002022-01-01
10653160317937CENTURIONTRI66800TRI668002022-01-02
10653160352914CENTURIONI68945I689452022-05-04
10653160370604CENTURIONI86900I869002024-01-31
00653160049756CENTURION67110671102021-12-31
00653160196863CENTURION67845678452022-01-01
10653160395980CENTURIONIV8885BIV8885B2026-10-29
10653160277361CenturionECT18234SCST2017-06-30
10653160309505CenturionART5052017-05-04
10653160319863CenturionSTCVC172018-08-17
10653160319870CenturionSTCVC182018-08-17
10653160319917CenturionSTCVC192018-08-17
10653160319924CenturionSTCVC202018-08-17
10653160319931CenturionSTCVC212018-08-17
10653160319948CenturionCVI3535A2018-08-17
10653160319986CenturionSTCVC222018-08-18
10653160321194CenturionCVI45102018-10-04
10653160324591CenturionART8852019-02-10
10653160326557CenturionART9052019-05-05
10653160327738CenturionGW1850IGW1850I2020-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454010143COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010150COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010167COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010174COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010181COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010198COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013243COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013250COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013267COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013274COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454000755COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454000762COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454006931COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454010129COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454010136COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454010204COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454012291COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454012840COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454012987COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013168COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013175COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013182COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013199COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013205COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013212COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013229COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013236COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
00850090726102Intrace USAPILOTIS TECH LLCEAX2026-10-31
00850090726119Intrace USAPILOTIS TECH LLCEAX2026-10-31
00840456225424JMUJMU DENTAL, INCEAX2026-10-14