Compass Steerable Needle

GUDID 00860009430228

Flexible endoscopic biopsy handpiece/needle

Primary Device ID	00860009430228
NIH Device Record Key	f0041a36-6c25-461c-bd1e-3863321bab34
Commercial Distribution Status	In Commercial Distribution
Brand Name	Compass Steerable Needle
Version Model Number	CSN1001
Company DUNS	118905661
Company Name	SERPEX MEDICAL INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 60 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00860009430228 [Primary]

KTI	Bronchoscope Accessory

Steralize Prior To Use	false
Device Is Sterile	true