Tensile Tape DFX0029S
GUDID 10854629006540
FF TensileTape White Size 2mm 30" heat stiffened cut lengths
DUNAMIS MEDICAL, LLC
Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament| Primary Device ID | 10854629006540 |
| NIH Device Record Key | 5df87482-aa0d-4c13-ab93-34b142b17485 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tensile Tape |
| Version Model Number | DFX0029S |
| Catalog Number | DFX0029S |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854629006543 [Primary] |
| GS1 | 10854629006540 [Package] Contains: 00854629006543 Package: box [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153746
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 | 2 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-07-05 |
On-Brand Devices [Tensile Tape]
| 00854629006673 | 1.5mm Blue 38" Tensile Tape |
| 10854629006540 | FF TensileTape White Size 2mm 30" heat stiffened cut lengths |
Trademark Results [Tensile Tape]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENSILE TAPE 87083148 not registered Dead/Abandoned |
Dunamis, LLC 2016-06-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.