SUTUMED
- Primary DI
- 07757093015437
- Brand
- SUTUMED
- Company
- Unilene S.A.C.
- Model
- SDNN050TC130
- Published
- 2023-01-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
unilene.comProduct Codes#
| Code | Name |
|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K123034 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07757093050858 | Package | GS1 | 12 | In Commercial Distribution |
| 07757093015437 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07757093050858 | 07757093050858 | 7757093050858 |
| 07757093015437 | 07757093015437 | 7757093015437 |
GMDN Terms#
| Term | Definition |
|---|---|
| Nylon suture, non-bioabsorbable, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. |
Contacts#
| Phone | |
|---|---|
| +051()997509089 | Marthalujan@unilene.com |
Regulatory Flags#
- DUNS number
- 934900072
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
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 |
|---|---|---|---|---|
| 07757093013747 | SUTUMED | Unilene S.A.C. | GAR | 2024-09-19 |
| 07757093013891 | SUTUMED | Unilene S.A.C. | GAR | 2024-09-19 |
| 07757093013068 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093013280 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093013563 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093013587 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093013600 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093013877 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093013952 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014041 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014096 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014188 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014362 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014393 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014560 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014713 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014744 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014768 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014881 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014898 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093014911 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015048 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015093 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015147 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015253 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015277 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015284 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015482 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015741 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |
| 07757093015765 | SUTUMED | Unilene S.A.C. | GAR | 2023-01-06 |