PERMA-HAND
- Primary DI
- 10705031023369
- Brand
- PERMA-HAND
- Company
- ETHICON, LLC
- Model
- C004D
- Catalog number
- C004D
- Device description
- Black Braided Silk, Nonabsorbable Surgical Suture
- Published
- 2015-09-01
- 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#
xxx.xxxProduct 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 |
|---|---|
| K946173 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30705031023363 | Package | GS1 | 12 | In Commercial Distribution |
| 10705031023369 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30705031023363 | 30705031023363 |
| 10705031023369 | 10705031023369 |
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. |
Contacts#
| Phone | |
|---|---|
| +1(877)384-4266 | xxx@xxx.xxx |
Regulatory Flags#
- DUNS number
- 829465157
- 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 |
|---|---|---|---|---|
| 10705031023727 | NUROLON | C503D | C503D | 2015-09-01 |
| 10705031023741 | NUROLON | C512D | C512D | 2015-09-01 |
| 10705031023758 | NUROLON | C513D | C513D | 2015-09-01 |
| 10705031023765 | NUROLON | C514D | C514D | 2015-09-01 |
| 10705031023888 | NUROLON | C553D | C553D | 2015-09-01 |
| 10705031023895 | NUROLON | C554D | C554D | 2015-09-01 |
| 10705031023918 | NUROLON | C563D | C563D | 2015-09-01 |
| 10705031023987 | NUROLON | C584D | C584D | 2015-09-01 |
| 10705031024199 | ETHIBOND EXCEL | CX12D | CX12D | 2015-09-01 |
| 10705031024205 | ETHIBOND EXCEL | CX13D | CX13D | 2015-09-01 |
| 10705031088054 | ETHILON | 1628H | 1628H | 2026-07-03 |
| 10705031089600 | ETHILON | 648H | 648H | 2026-07-03 |
| 10705031097018 | ETHILON | EH7553H | EH7553H | 2026-07-03 |
| 10705031099975 | ETHILON | FH5171H | FH5171H | 2026-07-03 |
| 17891338994365 | VICRYL RAPIDE | VR1626G | VR1626G | 2026-07-03 |
| 17891338994389 | VICRYL RAPIDE | VR1824H | VR1824H | 2026-07-03 |
| 17891338994396 | VICRYL RAPIDE | VR1828H | VR1828H | 2026-07-03 |
| 17891338994440 | VICRYL RAPIDE | VR1916G | VR1916G | 2026-07-03 |
| 17891338994457 | VICRYL RAPIDE | VR4890G | VR4890G | 2026-07-03 |
| 17891338994501 | VICRYL RAPIDE | VR612G | VR612G | 2026-07-03 |
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 |