Primary Device ID | 10810032661240 |
NIH Device Record Key | c7a0130a-fbe8-4145-8d0c-a9c7a2a41078 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hoopla Retractor |
Version Model Number | CIR0308 |
Catalog Number | CIR0308 |
Company DUNS | 068038277 |
Company Name | ZYRIS, INC. |
Device Count | 80 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 | false |
OTC Over-The-Counter | true |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810032661243 [Primary] |
GS1 | 10810032661240 [Unit of Use] |
EIF | ACCESSORIES, RETRACTOR, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-05-03 |
Device Publish Date | 2024-04-19 |
10810032661240 | Hoopla Retractor, Small, 80-Pack |
10810032661233 | Hoopla Retractor, Small, 40-Pack |
10810032661226 | Hoopla Retractor, Regular, 80-Pack |
10810032661219 | Hoopla Retractor, Regular, 40-Pack |