SUTUMED
- Primary DI
- 07757093060512
- Brand
- SUTUMED
- Company
- Unilene S.A.C.
- Model
- SDPP040MR150
- Published
- 2023-01-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
unilene.comProduct Codes#
| Code | Name |
|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K123034 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07757093060512 | Package | GS1 | 12 | In Commercial Distribution |
| 07757093025092 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07757093060512 | 07757093060512 | 7757093060512 |
| 07757093025092 | 07757093025092 | 7757093025092 |
GMDN Terms#
| Term | Definition |
|---|---|
| Polyolefin/fluoropolymer suture, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +051()997509089 | Marthalujan@unilene.com |
Regulatory Flags#
- DUNS number
- 934900072
- 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
- true
- 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 |
|---|---|---|---|---|
| 07757093013747 | SUTUMED | SDNN001TC360 | SDNN001TC360 | 2024-09-19 |
| 07757093013891 | SUTUMED | SDNN010MC360 | SDNN010MC360 | 2024-09-19 |
| 07757093049166 | SUTUMED | SDNN001TC360 | SDNN001TC360 | 2024-09-19 |
| 07757093049319 | SUTUMED | SDNN010MC360 | SDNN010MC360 | 2024-09-19 |
| 07757093023470 | SUTUMED | SDPP001MR360 | 2023-01-06 | |
| 07757093023500 | SUTUMED | SDPP001MR400 | 2023-01-06 | |
| 07757093023760 | SUTUMED | SDPP010MC360 | 2023-01-07 | |
| 07757093023838 | SUTUMED | SDPP010MR260 | 2023-01-07 | |
| 07757093023869 | SUTUMED | SDPP010MR360 | 2023-01-07 | |
| 07757093023890 | SUTUMED | SDPP010MR400 | 2023-01-07 | |
| 07757093023968 | SUTUMED | SDPP010RC600 | 2023-01-07 | |
| 07757093024033 | SUTUMED | SDPP010TC400 | 2023-01-07 | |
| 07757093024101 | SUTUMED | SDPP020MC260 | 2023-01-07 | |
| 07757093024118 | SUTUMED | SDPP020MC350 | 2023-01-07 | |
| 07757093024125 | SUTUMED | SDPP020MC360 | 2023-01-07 | |
| 07757093024217 | SUTUMED | SDPP020MR260 | 2023-01-07 | |
| 07757093024255 | SUTUMED | SDPP020MR350 | 2023-01-07 | |
| 07757093024330 | SUTUMED | SDPP020RC600 | 2023-01-07 | |
| 07757093024361 | SUTUMED | SDPP020TC190 | 2023-01-07 | |
| 07757093024385 | SUTUMED | SDPP020TC240 | 2023-01-07 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 08903837037824 | Trulene | HEALTHIUM MEDTECH LIMITED | GAW | 2024-07-11 |
| 07757093024767 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093024828 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093024859 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093024873 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025092 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025115 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025146 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025184 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025290 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025313 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025467 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025610 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025702 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025726 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025740 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093025832 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093026044 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093026136 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093026150 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093026280 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093026518 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093680543 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-09 |
| 07757093023760 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |
| 07757093023838 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |
| 07757093023869 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |
| 07757093023890 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |
| 07757093023968 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |
| 07757093024033 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |
| 07757093024101 | SUTUMED | Unilene S.A.C. | GAW | 2023-01-07 |