FDA.reportPublic FDA data

Centurion

Primary DI
20193489199687
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
EST0012BL
Catalog number
EST0012BL
Device description
PTFE COATED BLADE 2.5'
Published
2021-02-28
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
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489199687PackageGS112In Commercial Distribution
10193489199680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919968720193489199687
1019348919968010193489199680

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

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
false
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
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02
10653160270775CenturionSV65NXTSV65NXT2022-01-02

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Primary DI, Brand, Company table
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