Tensile Tape DFX0029S
GUDID 10854629006540
FF TensileTape White Size 2mm 30" heat stiffened cut lengths
DUNAMIS MEDICAL, LLC
Polyolefin 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 |
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