FDA.report

Centurion

Primary DI
10653160098379
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
PE2365
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MLTPelvic exam kit

Product Code Classifications

CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160098379PackageGS120In Commercial Distribution
00653160098372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316009837910653160098379
00653160098372006531600983726531600983720653160098372

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@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

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00653160388794CenturionSUT12485ASUT12485A2025-07-14

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