FDA.reportPublic FDA data

Centurion

Primary DI
00653160325669
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
MNS11905
Catalog number
MNS11905
Device description
ORL KIT
Published
2022-01-01
Public version status
New
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
EPYSPECULUM, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160325669PackageGS120In Commercial Distribution
10653160325666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160325669006531603256696531603256690653160325669
1065316032566610653160325666

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, single-useA hand-held surgical instrument which is inserted into a nostril and manually expanded to open the nostril to a maximum by stretching the tissue around the nasal orifice allowing the doctor or surgeon access for examination or surgery during ear/nose/throat (ENT) intervention. It is made of disposable materials and has two blunt, contoured blades that are operated by the operator applying pressure to the pivoted handles or other mechanism. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02
10653160292562CENTURIONMNS9820MNS98202022-01-02
10653160293798CENTURIONIV8310EIV8310E2017-08-18
10653160310006CENTURIONID2060ID20602021-11-29
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

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Primary DI, Brand, Company table
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00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
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