Image APN Posterior 1219567

GUDID 10304040000936

Image APN Posterior

HENRY SCHEIN, INC.

Resin artificial teeth
Primary Device ID10304040000936
NIH Device Record Keyc6b10654-519c-4907-8dd3-78833388e37e
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage APN Posterior
Version Model Number1219567
Catalog Number1219567
Company DUNS012430880
Company NameHENRY SCHEIN, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040000939 [Primary]
GS110304040000936 [Package]
Contains: 00304040000939
Package: BOX [20 Units]
In Commercial Distribution

FDA Product Code

ELMDenture, plastic, teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by HENRY SCHEIN, INC.

10304040081300 - Henry Schein2024-11-07 Maxima Suture PGA Undyed NP-3
10304040081317 - Henry Schein2024-11-07 Maxima Suture PGA Undyed NP-3
10304040081324 - Henry Schein2024-11-07 Maxima Suture PGA Undyed NPS-2
10304040081331 - Henry Schein2024-11-07 Maxima Suture PGA Undyed NPS-2
10304040081348 - Henry Schein2024-11-07 Maxima Suture PGA Undyed NFS-2
10304040081355 - Henry Schein2024-11-07 Maxima Suture PGA Undyed NFS-2
H65857037950 - Henry Schein2024-11-05 Maxima Advanced Chamber Sterilizer MA11 (110V)
H65857037960 - Henry Schein2024-11-05 Maxima Advanced Chamber Sterilizer MA11 (220V)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.