FDA.reportPublic FDA data

CENTURION

Primary DI
10653160349006
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
67850
Catalog number
67850
Device description
STERILE JACKSON RETRACTOR
Published
2021-11-29
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160349009PackageGS120In Commercial Distribution
10653160349006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160349009006531603490096531603490090653160349009
1065316034900610653160349006

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic examination kitA collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.

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
10653160286844CENTURIONI67350I673502022-01-01
00653160022360CENTURION66360663602021-12-31
10653160395225CENTURIONIVS4231IVS42312026-10-14
10653160395256CENTURIONIVS3945BIVS3945B2026-10-14
10653160395355CENTURIONCIT3065BCIT3065B2026-10-14
10653160395232CENTURIONCIT6750ACIT6750A2026-10-13
10653160393443CENTURIONDT23110DT231102026-10-08
10653160394075CENTURIONDT21660CDT21660C2026-10-08
10653160393344CENTURIONDM1348DM13482026-10-07
10653160393818CENTURIONDT15200CDT15200C2026-10-07
10653160394464CENTURIONDT12565ADT12565A2026-10-07
10653160320265CENTURIONID1945AID1945A2022-01-01
10653160365815CENTURIONI69005I690052023-09-05
20653160251610CENTURIONFCS300XTFCS300XT2022-01-01
00653160013191CENTURIONHT855HT8552017-08-25
10653160393450CENTURIONCVI5404CVI54042026-10-05
10653160394242CENTURIONCIT7621CIT76212026-10-05
10653160394297CENTURIONCHT1885ACHT1885A2026-10-05
10653160394570CENTURIONCIT2285ACIT2285A2026-10-05
10653160394754CENTURIONCIT5165ACIT5165A2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00810111228480RetractorTreace Medical Concepts, Inc.GAD2026-10-16
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12