B-4U INSTRUMENT B215

GUDID D7701488523

Rotary/reciprocating endodontic file/rasp, single-use

Primary Device ID	D7701488523
NIH Device Record Key	d9323b1c-9711-4a06-b2ac-bdb04b9fdf73
Commercial Distribution Status	In Commercial Distribution
Brand Name	B-4U INSTRUMENT
Version Model Number	B215
Catalog Number	B215
Company DUNS	433815198
Company Name	SWEDEN & MARTINA SPA
Device Count	1
DM Exempt	true
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	true
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

Device Issuing Agency	Device ID
HIBCC	D7701488523 [Primary]

NDP	Accessories, Implant, Dental, Endosseous

Steralize Prior To Use	false
Device Is Sterile	true

D7701824503	B-4U INSTRUMENT 0 STARTER L L. 31 MM, CONF 6 PZ - STERILE
D7701824483	B-4U INSTRUMENT 00 STARTER L L. 25 MM, CONF 6 PZ - STERILE
D7701488573	B-4U INSTRUMENT 2 FINISHER M L. 31 MM, CONF 6 PZ - STERILE
D7701488563	B-4U INSTRUMENT 1 FINISHER L. 31 MM, CONF 6 PZ - STERILE
D7701488553	B-4U INSTRUMENT 0 STARTER L. 31 MM, CONF 6 PZ - STERILE
D7701488543	B-4U INSTRUMENT 3 FINISHER L L. 25 MM, CONF 6 PZ - STERILE
D7701488533	B-4U INSTRUMENT 2 FINISHER M L. 25 MM, CONF 6 PZ - STERILE
D7701488523	B-4U INSTRUMENT 1 FINISHER L. 25 MM, CONF 6 PZ - STERILE
D7701488513	B-4U INSTRUMENT 0 STARTER L. 25 MM, CONF 6 PZ - STERILE