Sofsilk
- Primary DI
- 20884521086101
- Brand
- Sofsilk
- Company
- Covidien LP
- Model
- S-204
- Catalog number
- S-204
- Device description
- Wax Coated Braided Silk
- Published
- 2020-08-16
- Public version status
- New
- 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#
covidien.comProduct Codes#
| Code | Name |
|---|---|
| GAP | SUTURE, NONABSORBABLE, SILK |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K981128 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20884521086101 | Package | GS1 | 36 | In Commercial Distribution |
| 10884521086104 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20884521086101 | 20884521086101 |
| 10884521086104 | 10884521086104 |
GMDN Terms#
| Term | Definition |
|---|---|
| Silk suture, sterile | A sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 40 | Inch |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 0 Degrees Fahrenheit | 130 Degrees Fahrenheit | |
| Special Storage Condition, Specify | 0 | 0 | ; |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(508)261-8000 | covidien.udi@covidien.com |
Regulatory Flags#
- DUNS number
- 058614483
- 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 |
|---|---|---|---|---|
| 10884521620193 | Shiley | 18775S | 2017-04-18 | |
| 10884521620209 | Shiley | 18780S | 2017-01-06 | |
| 10884521543805 | Signia | SIGADAPTSTND | 2017-08-08 | |
| 10884521824355 | McGRATH | X3-003-000 | 2021-09-01 | |
| 10884521032903 | Biosyn | GMT-226 | 2015-09-01 | |
| 10884521073517 | Versaport | NBFCA5ST | 2016-09-24 | |
| 10884521085329 | Sofsilk | GSJ-36-M | 2015-09-01 | |
| 10884521085336 | Sofsilk | GSJ-37-M | 2015-09-01 | |
| 10884521101999 | Vascufil | 88864722-21V | 2015-08-31 | |
| 10884521191013 | Endo GIA | EGIATRS60AMT | 2015-09-01 | |
| 10884521543522 | Tri-Staple 2.0 | SIGC60VT | 2017-05-26 | |
| 10884521543638 | Tri-Staple 2.0 | SIGTRS60AMT | 2017-05-26 | |
| 10884521726352 | ReliaTack | RELTACK8RDPTSW | 2018-06-03 | |
| 10884523000627 | SILS | SILSHOOK36 | 2016-09-24 | |
| 10884523000917 | Surgiwand II | 178094 | 2016-09-24 | |
| 10884523006599 | Premium Plus CEEA | 111985 | 2015-08-28 | |
| 10884524001500 | Valleylab | E2516HS | 2016-09-24 | |
| 10884521195202 | Sonicision | SCD13 | 2018-08-10 | |
| 10884521807884 | Sonicision | SCD13 | 2020-06-29 | |
| 10884521546219 | LigaSure | LIGASUREZD | 2018-09-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07757093028192 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028222 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028260 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028536 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028734 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028833 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028888 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028956 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093028987 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029014 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029236 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029366 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029373 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029427 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029489 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029502 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029540 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029564 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029595 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029601 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093218463 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
| 07757093029809 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093029854 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093029878 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093029892 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093030027 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093030089 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093030256 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093030294 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093030331 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |