MONODEK
- Primary DI
- 34026704603924
- Brand
- MONODEK
- Company
- TELEFLEX INCORPORATED
- Model
- IPN000864
- Catalog number
- 833-137
- Device description
- Monodek Violet Monofilament Polydioxanone Size 0 48" TC43 Needle T Needle BSC
- Published
- 2019-01-14
- Public version status
- Update
- 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 |
|---|
| 34026704603924 | Package | GS1 | 12 | In Commercial Distribution |
| 14026704603920 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 34026704603924 | 34026704603924 |
| 14026704603920 | 14026704603920 |
GMDN Terms
| Term | Definition |
|---|
| Polyester suture, bioabsorbable, monofilament | A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | store at room temperature |
Regulatory Flags
- DUNS number
- 002348191
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 28800145520694 | V-Soft Line BARB STAR 21Gx60mm FDA | Feeltech Co.,Ltd. | NEW | 2026-03-19 |
| 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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