DFX Tensile Tape
- Primary DI
- 10854629006380
- Brand
- DFX Tensile Tape
- Company
- DUNAMIS MEDICAL, LLC
- Model
- DFX0027S
- Catalog number
- DFX0027S
- Device description
- DFX Tensile Tape 1.5 mm (UHMWPE) 18" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm
- Published
- 2018-01-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K153746 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10854629006380 | Package | GS1 | 12 | In Commercial Distribution |
| 00854629006383 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10854629006380 | 10854629006380 | ||
| 00854629006383 | 00854629006383 | 854629006383 | 0854629006383 |
GMDN Terms#
| Term | Definition |
|---|---|
| Polyolefin suture, multifilament | A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 731-217-2533 | dr.raj76@gmail.com |
Regulatory Flags#
- DUNS number
- 079471560
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10854629006847 | Fastloop™ White | DFX24SLW | 2022-03-03 | |
| 10854629006854 | Fastloop™ Green | DFX24SLG | 2022-03-03 | |
| 00850052601317 | Olecranon Transporter™ Repair Kit | OL-2000 | OL-2000 | 2025-04-29 |
| 00850052601294 | Force DFX Suture Loop -Xtreme™ | DFX34XSL | DFX0034S | 2025-04-10 |
| 40854629006916 | Orca™ Xtreme Knotless Button | AB-6900 | AB-6900 | 2024-01-31 |
| 00854629006956 | Enofix ™ with Constrictor® Technology Syndesmotic Fixation Kit | 3500-00-0001 | 3500-00-0001 | 2023-07-31 |
| 00850052601263 | Constrictor® Mini 2.0 Syndesmosis Repair Kit | AB-3700 | AB-3700 | 2024-09-19 |
| 00850052601270 | Constrictor® 2.0 Syndesmosis Repair Kit | AB-2700 | AB-2700 | 2024-09-19 |
| 00854629006789 | Constrictor® Mini Syndesmosis Repair Kit | AB-3200 | AB-3200 | 2024-09-19 |
| 00850052601256 | Micro Constrictor ®X Repair Kit | AB-8700 | AB-8700 | 2024-09-19 |
| 00850052601249 | Orca™ Implantation Kit | AB-6250 | AB-6250 | 2024-06-20 |
| 00850052601072 | Hallux Guide | DU1000 | DU1000 | 2024-06-10 |
| 00850052601089 | CMC Spacer | DNS000/DNS001 | DNS000/DNS001 | 2024-06-10 |
| 00850052601096 | CMC Guide | DU3000 | DU3000 | 2024-06-10 |
| 00850052601157 | Threaded Driver | 1001610 | 1001610 | 2024-06-10 |
| 00850052601232 | Micro Constrictor® Implantation Kit | AB-8250 | AB-6950 | 2024-06-10 |
| 00850052601225 | Orca Xtreme ™ Kit Knotless Button | AB-6925 | AB-6925 | 2024-03-14 |
| 00850052601218 | Orca™ Xtreme Implantation Kit | AB-6950 | AB-6950 | 2024-02-13 |
| 00854629006147 | PunchTac 3mm Anchor PEEK | DFX0028A | DFX0028A | 2017-04-11 |
| 00854629006161 | PunchTac 3.5mm Anchor PEEK | DFX0029A | DFX0029A | 2017-04-11 |
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|---|---|---|---|---|
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