Sofsilk
- Primary DI
- 10884521086104
- Brand
- Sofsilk
- Company
- Covidien LP
- Model
- S-204
- Device description
- Wax Coated Braided Silk
- Published
- 2020-08-16
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- 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 | Not 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 | "A 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 device(s) [e.g., needle, passer] intended to facilitate suture application. 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 |
Contacts#
| Phone | |
|---|---|
| +1(508)261-8000 | covidien.udi@covidien.com |
Regulatory Flags#
- DUNS number
- 058614483
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10884521758803 | Vascufil | 8886470311V-2 | 2020-07-19 | |
| 20884521082868 | VersaStep | VS101505 | 2016-09-24 | |
| 10884521038967 | Valleylab | E250510FRNSB | 2025-03-27 | |
| 10884524002880 | Valleylab | E250510FRNSB | 2025-03-27 | |
| 10884521039100 | Valleylab | E3310NSB | 2016-09-24 | |
| 10884521141117 | WarmTouch | 5030890 | 2019-02-06 | |
| 10884521205024 | Shiley | 4CN65R | 2016-09-24 | |
| 10884521205420 | Shiley | 5CN70R | 2016-09-24 | |
| 10884521205437 | Shiley | 6CN75R | 2016-09-24 | |
| 10884521205444 | Shiley | 7CN80R | 2016-09-24 | |
| 10884521205451 | Shiley | 8CN85R | 2016-09-24 | |
| 10884521205468 | Shiley | 9CN90R | 2016-09-24 | |
| 10884521205475 | Shiley | 10CN10R | 2016-09-24 | |
| 10884521205482 | Shiley | 4UN65R | 2016-09-24 | |
| 10884521205499 | Shiley | 5UN70R | 2016-09-24 | |
| 10884521205505 | Shiley | 6UN75R | 2016-09-24 | |
| 10884521205512 | Shiley | 7UN80R | 2016-09-24 | |
| 10884521205529 | Shiley | 8UN85R | 2016-09-24 | |
| 10884521205536 | Shiley | 9UN90R | 2016-09-24 | |
| 10884521205543 | Shiley | 10UN10R | 2016-09-24 |
Other Devices Sharing Product Codes#
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| 07757093028734 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
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| 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 |
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| 07757093029427 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-09 |
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| 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 |
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| 07757093030294 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |
| 07757093030331 | SUTUMED | Unilene S.A.C. | GAP | 2023-01-06 |