FENTANYL PLUS LEVEL 2

GUDID B80003716500041

Opiate/opiate metabolite IVD, control

Primary Device ID	B80003716500041
NIH Device Record Key	7b024c65-ddb4-4747-b404-e98e9dd027ff
Commercial Distribution Status	In Commercial Distribution
Brand Name	FENTANYL PLUS LEVEL 2
Version Model Number	FENT+ 2 U PM
Company DUNS	092519016
Company Name	UTAK LABORATORIES, 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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B80003716500040 [Primary]
HIBCC	B80003716500041 [Package] Contains: B80003716500040 Package: Box [4 Units] In Commercial Distribution
HIBCC	B80003716500042 [Package] Contains: B80003716500040 Package: Box [5 Units] In Commercial Distribution
HIBCC	B80003716500043 [Package] Contains: B80003716500040 Package: Box [10 Units] In Commercial Distribution
HIBCC	B80003716500046 [Package] Contains: B80003716500040 Package: Box [25 Units] In Commercial Distribution
HIBCC	B80003716500047 [Package] Contains: B80003716500040 Package: Box [50 Units] In Commercial Distribution
HIBCC	B80003716500048 [Package] Contains: B80003716500040 Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false