LATERA
GUDID 00857037006082
Latera 24mm Absorbable Nasal Implant
ENTELLUS MEDICAL, INC.
Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal implant, synthetic polymer, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, bioabsorbable Nasal cartilage support implant, 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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