Provox Dilator 17 7122

GUDID 07331791000393

The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture.

Atos Medical AB

Tracheoesophageal fistula dilator

Primary Device ID	07331791000393
NIH Device Record Key	c18f0ba0-4dc4-43d0-b371-eb3c382047c1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Provox Dilator 17
Version Model Number	7122
Catalog Number	7122
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 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791000393 [Primary]

FDA Product Code

LRC	Instrument, Ent Manual Surgical