The O.R. Company LLC

GUDID 04715309122884

Hysterosonography/endometrial biopsy catheter

Primary Device ID	04715309122884
NIH Device Record Key	8619aadb-d300-45be-ba68-994931d2b1ad
Commercial Distribution Status	In Commercial Distribution
Brand Name	The O.R. Company LLC
Version Model Number	UMI 4.5KC-D
Company DUNS	657528899
Company Name	PANPAC MEDICAL CORPORATION
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	true
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

Device Issuing Agency	Device ID
GS1	04715309122884 [Package] Contains: 04715309122914 Package: BOX [12 Units] In Commercial Distribution
GS1	04715309122914 [Primary]
GS1	04715309122921 [Package] Package: carton [10 Units] In Commercial Distribution

LKF	Cannula, Manipulator/Injector, Uterine

Steralize Prior To Use	false
Device Is Sterile	true

04715309122884	"Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparoto
04715309122877	"Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparoto