Primary Device ID | M927600440 |
NIH Device Record Key | 34a8a7ae-30f8-4bbf-badd-3ccdfc9bd884 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PROPEL Mini Sinus Implant with Straight Delivery System |
Version Model Number | 60044 |
Company DUNS | 876715355 |
Company Name | Intersect Ent, Inc. |
Device Count | 1 |
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 | true |
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 |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Stent Length | 18 Millimeter |
Maximum Stent Diameter | 42.5 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M927600440 [Primary] |
OWO | Drug-Eluting Sinus Stent |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-03-17 |
Device Publish Date | 2020-10-26 |
M927700110 - Propel | 2022-03-17 |
M927500110 - Propel Contour | 2022-03-17 |
M927600110 - Propel Mini | 2022-03-17 |
M927600440 - PROPEL Mini Sinus Implant with Straight Delivery System | 2022-03-17 |
M927600440 - PROPEL Mini Sinus Implant with Straight Delivery System | 2022-03-17 |