INTRODUCER

GUDID 08052286590159

Interventional radiology percutaneous-access procedure kit

Primary Device ID	08052286590159
NIH Device Record Key	4e190e22-9cc0-401f-828c-12ba5f3d536a
Commercial Distribution Status	In Commercial Distribution
Brand Name	INTRODUCER
Version Model Number	EI AG2 0020 620
Company DUNS	895683282
Company Name	ELESTA SPA
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08052286590135 [Primary]
GS1	08052286590159 [Package] Contains: 08052286590135 Package: carton box [20 Units] In Commercial Distribution

GAA	Needle, Aspiration And Injection, Disposable

Steralize Prior To Use	false
Device Is Sterile	true

08052286590166	CHIBA introducer needle, 21Gx20.7 cm
08052286590159	CHIBA introducer needle, 21Gx11.7 cm