FDA.report

Sertera Introducer

Primary DI
15420045504189
Brand
Sertera Introducer
Company
Hologic, Inc.
Model
Sertera Intro-14
Catalog number
Sertera Intro-14
Published
2017-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
25420045504186PackageGS15In Commercial Distribution
15420045504189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2542004550418625420045504186
1542004550418915420045504189

GMDN Terms

TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags

DUNS number
018925968
Device count
1
DM exempt
true
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
false
Sterilization required before use
true

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