Primary Device ID | 10857326005533 |
NIH Device Record Key | 83e4c519-8e64-4682-92a2-a7a8fb0d2144 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XeroGel Nasal/Epistaxis 2 Pack |
Version Model Number | XG-102 |
Company DUNS | 017283879 |
Company Name | ENTELLUS MEDICAL, INC. |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
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 |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857326005536 [Primary] |
GS1 | 10857326005533 [Unit of Use] |
LYA | Splint, Intranasal Septal |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-18 |
Device Publish Date | 2020-09-10 |
00850002250237 - TGS | 2023-07-07 Universal Headrest |
00850002250244 - TGS | 2023-07-07 Universal Headrest Mounting Arm |
00850002250251 - TGS | 2023-07-07 Universal Headrest Adapter A |
00850002250268 - TGS | 2023-07-07 Universal Headrest Adapter B |
00850002250275 - TGS | 2023-07-07 Universal Headrest Adapter C |
00857326005567 - FocESS | 2023-07-07 HD Wireless Camera |
00857326005581 - Portable Red LED Light Source | 2023-07-07 LED light source, red |
00857326005536 - XeroGel | 2023-07-07 Nasal Epistaxis 2 Pack |