ETHILON
- Primary DI
- 10705031099975
- Brand
- ETHILON
- Company
- ETHICON, LLC
- Model
- FH5171H
- Catalog number
- FH5171H
- Device description
- Black dyed Monofilament, Synthetic Nonabsorbable Suture
- Published
- 2026-07-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
xxx.xxxProduct 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 |
|---|---|
| K946173 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30705031099979 | Package | GS1 | 36 | In Commercial Distribution |
| 10705031099975 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 30705031099979 | 30705031099979 |
| 10705031099975 | 10705031099975 |
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 | |
|---|---|
| +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 |
|---|---|---|---|---|
| 10705031023369 | PERMA-HAND | C004D | C004D | 2015-09-01 |
| 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 |
| 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 |
|---|---|---|---|---|
| 10705031088054 | ETHILON | ETHICON, LLC | GAR | 2026-07-03 |
| 10705031089600 | ETHILON | ETHICON, LLC | GAR | 2026-07-03 |
| 10705031097018 | ETHILON | ETHICON, LLC | GAR | 2026-07-03 |
| 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 |