Novafil
Monofilament Polybutester,CV-11,D/A,1x Blue Strand
6manufacturers in China registered for this device type
112catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| 510(k) | K990952 |
| Record published | 2015-08-30 |
| Record revised | 2025-06-24 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 12, case of 36, case of 24, pack_or_inner_pack of 12 |
| Sizes | Length 12 to 96 in |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8886 4410-03 | Length 18 in | In distribution |
| 8886 4410-13 | Length 18 in | In distribution |
| 8886 4002-41 | Length 36 in | In distribution |
| 8886 4458-53 | Length 18 in | In distribution |
| 88864470-71 | Length 60 in | In distribution |
| SPB-5142G | Length 18 in | In distribution |
| 88864582-53 | Length 30 in | In distribution |
| 8886 4420-33 | Length 18 in | In distribution |
| 8886 4455-61 | Length 30 in | In distribution |
| 8886 4455-71 | Length 30 in | In distribution |
| 8886 4414-31 | Length 18 in | In distribution |
| 88864490-41 | Length 30 in | In distribution |
| 8886 4403-43 | Length 18 in | In distribution |
| 8886 4032-31 | Length 30 in | In distribution |
| 8886 4408-61 | Length 60 in | In distribution |
| 8886 4401-33 | Length 18 in | In distribution |
| SPB-1623G | Length 18 in | In distribution |
| 8886 4402-33 | Length 18 in | In distribution |
| PB-6723K | diameter,5/0,N/A; | In distribution |
| 8886 4452-51 | Length 30 in | In distribution |
| 8886 4452-41 | Length 30 in | In distribution |
| 8886 4424-51 | Length 30 in | In distribution |
| 8886 4424-61 | Length 30 in | In distribution |
| 8886 4426-51 | Length 30 in | In distribution |
| 8886 4415-43 | Length 18 in | In distribution |
| 88864619-51 | Length 60 in | In distribution |
| 8886 4460-63 | Length 18 in | In distribution |
| 8886 4424-31 | Length 30 in | In distribution |
| 88864469-71 | Length 30 in | In distribution |
| 8886 4426-41 | Length 30 in | In distribution |
| 8886 4459-51 | Length 30 in | In distribution |
| 8886 4402-43 | Length 18 in | In distribution |
| SPB-5223G | Length 18 in | In distribution |
| 88864555-23 | Length 18 in | In distribution |
| 8886 4009-63 | Length 40 in | In distribution |
| 88864465-71 | diameter,1,N/A; | In distribution |
| XX-5141 | Length 40 in | In distribution |
| 8886 4422-33 | Length 18 in | In distribution |
| SPB-5833G | Length 18 in | In distribution |
| 88864463-71 | Length 30 in | In distribution |
| 88864470-81 | Length 60 in | In distribution |
| 8886 4403-33 | Length 18 in | In distribution |
| SPB-1213G | Length 18 in | In distribution |
| 88864490-51 | Length 30 in | In distribution |
| 88864464-73 | Length 18 in | In distribution |
| 8886 4401-23 | Length 18 in | In distribution |
| 8886 4421-53 | Length 30 in | In distribution |
| 8886 4420-13 | Length 18 in | In distribution |
| 8886 4420-23 | Length 18 in | In distribution |
| XX-5140 | Length 40 in | In distribution |
| SPB-5633G | Length 18 in | In distribution |
| XX-5011 | Length 48 in | In distribution |
| 88864554-41 | Length 30 in | In distribution |
| 8886 4418-53 | diameter,2/0,N/A; | In distribution |
| CPB-738G | Length 40 in | In distribution |
| 88864582-43 | Length 30 in | In distribution |
| 88864469-61 | Length 30 in | In distribution |
| SPB-5433G | Length 18 in | In distribution |
| 8886 4400-23 | Length 18 in | In distribution |
| 8886 4420-43 | Length 18 in | In distribution |
| PB-6713K | Length 12 in | In distribution |
| 8886 4454-73 | Length 18 in | In distribution |
| XX-5144 | diameter,0,N/A; | In distribution |
| 8886 4459-61 | Length 30 in | In distribution |
| 8886 4433-71 | Length 30 in | In distribution |
| 8886 4400-13 | Length 18 in | In distribution |
| 8886 4410-23 | Length 18 in | In distribution |
| 8886 4419-23 | Length 18 in | In distribution |
| 8886 4426-61 | Length 30 in | In distribution |
| 88864538-63 | Length 80 in | In distribution |
| 8886 4436-71 | Length 30 in | In distribution |
| 8886 4458-63 | Length 18 in | In distribution |
| X-7005 | Length 30 in | In distribution |
| 8886 4452-61 | Length 30 in | In distribution |
| 8886 4422-43 | Length 18 in | In distribution |
| 8886 4402-23 | Length 18 in | In distribution |
| 8886 4401-13 | Length 18 in | In distribution |
| 8886 4419-33 | Length 18 in | In distribution |
| 8886 4450-41 | Length 30 in | In distribution |
| SPB-5843G | Length 18 in | In distribution |
| 8886 4425-31 | Length 30 in | In distribution |
| 8886 4028-21 | Length 30 in | In distribution |
| 8886 4424-41 | Length 30 in | In distribution |
| 8886 4419-13 | Length 18 in | In distribution |
| 8886 4422-53 | Length 18 in | In distribution |
| SPB-1643G | diameter,3/0,N/A; | In distribution |
| 8886 4459-71 | Length 30 in | In distribution |
| 8886 4028-31 | Length 30 in | In distribution |
| SPB-1233G | Length 18 in | In distribution |
| SPB-5143G | Length 18 in | In distribution |
| 8886 4454-63 | Length 18 in | In distribution |
| 88864465-81 | Length 30 in | In distribution |
| SPB-5413G | Length 18 in | In distribution |
| 8886 4027-21 | Length 30 in | In distribution |
| XNF-1994 | diameter,4/0,N/A; | Withdrawn |
| XNF-1964 | diameter,4/0,N/A; | Withdrawn |
| XX-5121-L | Length 60 in | Withdrawn |
| X-1183-L | Length 96 in | Withdrawn |
| X-1349 | diameter,1,N/A; | Withdrawn |
| XNF-1965 | Length 18 in | Withdrawn |
| 8886 4422-63 | Length 18 in | Withdrawn |
| XNF-697 | Length 18 in | Withdrawn |
| XNF-1995 | diameter,5/0,N/A; | Withdrawn |
| 8886 4456-61 | Length 30 in | Withdrawn |
| SPB-1945G | Length 18 in | Withdrawn |
| PB-7740K | Length 12 in | Withdrawn |
| XNF-1955 | Length 18 in | Withdrawn |
| XNF-1993 | Length 18 in | Withdrawn |
| XX2214 | Diameter, 5/0, N/A; | Withdrawn |
| X-1321 | Length 30 in | Withdrawn |
| XNF-1966 | diameter,6/0,N/A; | Withdrawn |
| SPB-5423G | Length 18 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 48492 units |
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 40152 units |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.