LATERA
GUDID 00857037006082
Latera 24mm Absorbable Nasal Implant
ENTELLUS MEDICAL, INC.
Nasal implant, synthetic polymer, bioabsorbable| Primary Device ID | 00857037006082 |
| NIH Device Record Key | 6061d151-8086-4a2c-9709-d11b5469680c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LATERA |
| Version Model Number | LATANI24 |
| Company DUNS | 017283879 |
| Company Name | ENTELLUS MEDICAL, 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 | 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 |
Device Dimensions
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
| Length | 24 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 38 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857037006082 [Primary] |
| GS1 | 00857037006129 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161191
FDA Product Code
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-14 |
| Device Publish Date | 2018-06-04 |
On-Brand Devices [LATERA]
| 00857037006921 | nasal implant delivery device |
| 00857037006082 | Latera 24mm Absorbable Nasal Implant |
| 00857037006044 | absorbable nasal implant |
| 00857037006983 | absorbable nasal implant |
| 00857037006990 | nasal implant delivery device |
| 00857037006020 | 20mm Latera Delivery Device |
| 00857037006105 | Latera 24 mm Delivery Device |
| 00857037006037 | Latera 20mm Absorbable Nasal Implant System |
| 00857037006013 | Latera 20mm Absorbable Nasal Implants |
| 00857037006075 | Latera 24mm Absorbable Nasal Implant System |
Trademark Results [LATERA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LATERA 87156020 5171540 Live/Registered |
Spirox, Inc. 2016-08-30 |
 LATERA 86958644 5130452 Live/Registered |
Spirox, Inc. 2016-03-30 |
 LATERA 85535925 4440823 Live/Registered |
Precision Architectural Lighting, Inc. 2012-02-07 |
 LATERA 79066829 3734473 Dead/Cancelled |
LINET, spol. s r.o. 2008-09-24 |
 LATERA 79045105 3654825 Dead/Cancelled |
LINET spol. s r.o. 2007-05-21 |
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