NEEDLE EP003997S BROCKENBROUG PEDIATRIC Medical Device Identification

GUDID 00613994663153

Cardiac transseptal needle

Primary Device ID	00613994663153
NIH Device Record Key	850ae6e1-bfcf-4c8b-b630-79f2429400fc
Commercial Distribution Status	In Commercial Distribution
Version Model Number	EP003997S
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00613994663153 [Primary]

Trocar

Steralize Prior To Use	false
Device Is Sterile	true