Provox Dilator 7211

GUDID 07331791000850

The Provox Dilator is intended for upsizing smaller tracheo-esophageal (TE) punctures (i.e. from 16 Fr diameter) to allow fitting of Provox voice prostheses, or upsizing a shrunken puncture to an adequate diameter, i.e. after loss of a voice prosthesis. The dilator may also be used for temporary blockage of a TE puncture or to temporarily prevent such from shrinkage. It is only intended to be used by physicians or speech pathologists/therapists trained in the care and rehabilitation of laryngectomized.

Atos Medical AB

Tracheoesophageal fistula dilator

Primary Device ID	07331791000850
NIH Device Record Key	a2e57116-ab19-4c34-8f03-8b17dc2bf1a2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Provox Dilator
Version Model Number	7211
Catalog Number	7211
Company DUNS	355470923
Company Name	Atos Medical AB
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
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	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791000850 [Primary]

FDA Product Code

LRC	Instrument, Ent Manual Surgical