STRATAFIX
- Primary DI
- 20705031465166
- Brand
- STRATAFIX
- Company
- ETHICON, LLC
- Model
- SXPP2B203
- Catalog number
- SXPP2B203
- Device description
- Stratafix (Spiral PDS Plus), Bidirectional
- Published
- 2023-08-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| NEW | Suture, surgical, absorbable, polydioxanone |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20705031465166 | Package | GS1 | 12 | In Commercial Distribution |
| 10705031465169 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 20705031465166 | 20705031465166 |
| 10705031465169 | 10705031465169 |
GMDN Terms
| Term | Definition |
|---|
| Barbed polyester suture, antimicrobial | A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester, and containing an agent to locally inhibit bacterial growth, intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is absorbed by hydrolysis. This is a single-use device. |
Regulatory Flags
- DUNS number
- 829465157
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- true
- 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
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|---|
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| 28800145520939 | V-Soft Line BARB BLUNT CANNULA 23Gx60mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145521134 | V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145521172 | V-Soft Line BARB BLUNT CANNULA L 21Gx90mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145521851 | V-Soft Line BARB BLUNT CANNULA L 19Gx40mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145522131 | V-Soft Line ARTE2 18Gx100mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145522810 | V-Soft Line MONO 27Gx50mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145523091 | V-Soft Line MONO 29Gx50mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 28800145523374 | V-Soft Line SCREW 27Gx50mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 00810126505378 | Basik | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | NEW | 2026-03-05 |
| 00817169022466 | Basik By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | NEW | 2026-03-05 |
| 00817169022473 | Basik By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | NEW | 2026-03-05 |
| 00817169022480 | Basik By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | NEW | 2026-03-05 |
| 00817169022497 | Basik By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | NEW | 2026-03-05 |
| 28800145524197 | Miracu FCL FORTE 18Gx100mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524203 | Miracu FCL FORTE 19Gx70mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524210 | Miracu FCL FORTE 19Gx100mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524265 | Miracu FCL FORTE FIX 18Gx100mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524272 | Miracu FCL FORTE FIX 19Gx70mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524302 | Miracu FCV Line 17Gx70mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524319 | iracu FCV Line 17Gx100mm | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524395 | Miracu MONO 27Gx40mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524401 | Miracu MONO 27Gx50mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524425 | Miracu MONO 27Gx60mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524432 | Miracu MONO 27Gx90mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524456 | Miracu MONO 29Gx40mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524470 | Miracu MONO 29Gx50mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 28800145524487 | Miracu MONO 29Gx60mm FDA | Feeltech Co.,Ltd. | NEW | 2026-02-26 |
| 30705031470624 | PDS | ETHICON, LLC | NEW | 2026-01-29 |
| 28800145520687 | V-Soft Line BARB STAR 19Gx90mm FDA | Feeltech Co.,Ltd. | NEW | 2026-01-23 |
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