Hoopla Retractor CIR0308

GUDID 10810032661240

Hoopla Retractor, Small, 80-Pack

ZYRIS, INC.

Hand-held dental retractor
Primary Device ID10810032661240
NIH Device Record Keyc7a0130a-fbe8-4145-8d0c-a9c7a2a41078
Commercial Distribution StatusIn Commercial Distribution
Brand NameHoopla Retractor
Version Model NumberCIR0308
Catalog NumberCIR0308
Company DUNS068038277
Company NameZYRIS, INC.
Device Count80
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810032661243 [Primary]
GS110810032661240 [Unit of Use]

FDA Product Code

EIFACCESSORIES, RETRACTOR, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-03
Device Publish Date2024-04-19

On-Brand Devices [Hoopla Retractor]

10810032661240Hoopla Retractor, Small, 80-Pack
10810032661233Hoopla Retractor, Small, 40-Pack
10810032661226Hoopla Retractor, Regular, 80-Pack
10810032661219Hoopla Retractor, Regular, 40-Pack

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