Novafil 8886 4028-31
GUDID 20884521099514
Monofilament Polybutester
Covidien LP
Polyester suture, non-bioabsorbable, monofilament| Primary Device ID | 20884521099514 |
| NIH Device Record Key | 3a032376-d02b-4636-b51c-1990db65a301 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Novafil |
| Version Model Number | 8886 4028-31 |
| Catalog Number | 8886 4028-31 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521099517 [Primary] |
| GS1 | 20884521099514 [Package] Contains: 10884521099517 Package: CASE [36 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990952
FDA Product Code
| GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2015-08-30 |
On-Brand Devices [Novafil]
| 10884521100633 | Monofilament Polybutester |
| 20884521100913 | Monofilament Polybutester |
| 20884521100753 | Monofilament Polybutester |
| 20884521100739 | Monofilament Polybutester |
| 20884521118383 | Monofilament Polybutester |
| 20884521118437 | Monofilament Polybutester,DX-19,1x Blue Strand |
| 20884521118420 | Monofilament Polybutester |
| 20884521101040 | Monofilament Polybutester |
| 20884521101019 | Monofilament Polybutester |
| 20884521100982 | Monofilament Polybutester |
| 20884521100975 | Monofilament Polybutester |
| 20884521100968 | Monofilament Polybutester |
| 20884521100876 | Monofilament Polybutester |
| 20884521100852 | Monofilament Polybutester |
| 20884521584638 | Monofilament Polybutester, DX-13, 1x Clear Strand |
| 20884521164854 | Monofilament Polybutester |
| 20884521163574 | Monofilament Polybutester |
| 20884521133386 | Monofilament Polybutester |
| 20884521118444 | Monofilament Polybutester,DX-11,1x Blue Strand |
| 20884521118413 | Monofilament Polybutester,CV-11,D/A,1x Blue Strand |
| 20884521118406 | Monofilament Polybutester |
| 20884521118390 | Monofilament Polybutester |
| 20884521118369 | Monofilament Polybutester |
| 20884521118352 | Monofilament Polybutester |
| 20884521118345 | Monofilament Polybutester |
| 20884521118338 | Monofilament Polybutester |
| 20884521118321 | Monofilament Polybutester |
| 20884521118314 | Monofilament Polybutester |
| 20884521101064 | Monofilament Polybutester |
| 20884521101057 | Monofilament Polybutester |
| 20884521101026 | Monofilament Polybutester |
| 20884521100999 | Monofilament Polybutester |
| 20884521100906 | Monofilament Polybutester |
| 20884521100890 | Monofilament Polybutester |
| 20884521100883 | Monofilament Polybutester |
| 20884521100869 | Monofilament Polybutester |
| 20884521100838 | Monofilament Polybutester |
| 20884521100821 | Monofilament Polybutester |
| 20884521100814 | Monofilament Polybutester |
| 20884521100807 | Monofilament Polybutester |
| 20884521100791 | Monofilament Polybutester |
| 20884521100777 | Monofilament Polybutester |
| 20884521100760 | Monofilament Polybutester |
| 20884521100722 | Monofilament Polybutester |
| 20884521100708 | Monofilament Polybutester |
| 20884521100692 | Monofilament Polybutester |
| 20884521100685 | Monofilament Polybutester |
| 20884521100661 | Monofilament Polybutester |
| 20884521100654 | Monofilament Polybutester |
| 20884521100647 | Monofilament Polybutester |
Trademark Results [Novafil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVAFIL 77015117 3271226 Live/Registered |
Nova Sports USA, Inc. 2006-10-05 |
 NOVAFIL 76416566 not registered Dead/Abandoned |
SLEEP INNOVATIONS INC. 2002-05-23 |
 NOVAFIL 73409843 1301418 Live/Registered |
American Cyanamid Company 1983-01-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.