0400655000

GUDID 04546540903839

Surgical helmet system

Primary Device ID	04546540903839
NIH Device Record Key	c93b9c2b-e589-4986-96c7-c1220cb5259b
Commercial Distribution Status	In Commercial Distribution
Version Model Number	0400655000
Catalog Number	0400655000
Company DUNS	196548481
Company Name	STRYKER CORPORATION
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	false
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

Phone	+1(800)253-3210
Email	Inst.Stryker.cs@Stryker.com

Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Issuing Agency	Device ID
GS1	04546540903839 [Primary]

FXZ	HELMET, SURGICAL

Steralize Prior To Use	false
Device Is Sterile	false