TAP TAP

GUDID D745TAP0

Device for treatment of mild to moderate obstructive sleep apnea

James R. Glidewell, Dental Ceramics, Inc.

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD745TAP0
NIH Device Record Key293ebb80-6018-495d-84e4-a0a65c34f346
Commercial Distribution StatusIn Commercial Distribution
Brand NameTAP
Version Model NumberTAP
Catalog NumberTAP
Company DUNS021228671
Company NameJames R. Glidewell, Dental Ceramics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX
Phone+1(800)854-7256
EmailXX@XX.XX

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD745TAP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, anti-snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

On-Brand Devices [TAP]

D745TAP0Device for treatment of mild to moderate obstructive sleep apnea
D745TAPF0flexTAP®

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