PROLENE D9835
GUDID 10705031035140
Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
ETHICON, LLC
Polyolefin suture, monofilament| Primary Device ID | 10705031035140 |
| NIH Device Record Key | 8724d845-22b3-48cd-9bd3-f039a74961a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROLENE |
| Version Model Number | D9835 |
| Catalog Number | D9835 |
| Company DUNS | 079402290 |
| Company Name | ETHICON, LLC |
| 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(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx | |
| Phone | +1(877)384-4266 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705031035140 [Primary] |
| GS1 | 30705031035144 [Package] Package: BOX [36 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133356
FDA Product Code
| GAW | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
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 | 2020-02-19 |
| Device Publish Date | 2015-09-01 |
On-Brand Devices [PROLENE]
| 30705031017492 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 30705031464265 | Blue Monofilament Polypropylene, Nonabsorbable Surgical Suture |
| 10705031231719 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031032279 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031030732 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031029958 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031029552 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 20705031464909 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 30705031238279 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031019294 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 30705031203581 | Blue Monofilament Polypropylene, Sterile Non-Absorbable Suture |
| 10705031203518 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 30705031134816 | Blue Monofilament Polypropylene, Sterile Non-Absorbable Suture |
| 30705031134809 | Blue Monofilament Polypropylene, Sterile Non-Absorbable Suture |
| 10705031134218 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031050518 | Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh |
| 20705031050508 | Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh |
| 10705031050495 | Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh |
| 20705031050485 | Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh |
| 20705031050478 | Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh |
| 20705031050461 | Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh |
| 10705031036611 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031036604 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035805 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035799 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035782 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035683 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035652 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035621 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035546 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035409 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035140 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031035065 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031034754 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031034747 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031034006 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031033993 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031033061 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031033047 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031032781 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031032774 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031032750 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031032378 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031031982 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031031944 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031031913 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031031791 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031031623 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031030404 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
| 10705031030190 | Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture |
Trademark Results [PROLENE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROLENE 74672885 2106165 Dead/Cancelled |
Omnicology, Inc. 1995-05-12 |
 PROLENE 73760455 1593027 Live/Registered |
CHEMPLEX INDUSTRIES, INC. 1988-10-28 |
 PROLENE 73401108 1267226 Live/Registered |
Carisbrook Industries, Inc. 1982-10-29 |
 PROLENE 73064683 1038758 Live/Registered |
ETHICON, INC. 1975-10-01 |
 PROLENE 72314211 0882961 Live/Registered |
ETHICON, INC. 1968-12-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.