AnchorKnot Suture
- Primary DI
- 10685447000478
- Brand
- AnchorKnot Suture
- Company
- Baylis Médicale Cie Inc
- Model
- ASU-2-WB-CL
- Device description
- Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
- Published
- 2016-11-30
- 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#
baylismedical.comProduct Codes#
| Code | Name |
|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K151009 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10685447000478 | Package | GS1 | 10 | In Commercial Distribution |
| 00685447000471 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10685447000478 | 10685447000478 | ||
| 00685447000471 | 00685447000471 | 685447000471 | 0685447000471 |
GMDN Terms#
| Term | Definition |
|---|---|
| Polyolefin suture, multifilament | A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) 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 needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 30 | Inch |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 5144889801 | info@baylismedical.com |
Regulatory Flags#
- DUNS number
- 249225954
- 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
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|---|---|---|---|---|
| 00685447018841 | VersaCross Connect Transseptal Dilator | VXA12-84-35-PS-D1 | NA | 2023-08-15 |
| 00685447006978 | Epicardial Steerable Guiding Sheath | ESK85-35-BD-45S | NA | 2022-07-21 |
| 00685447007623 | Epicardial Introducer and Stylet | EPI85-35-15-BS | NA | 2022-07-21 |
| 00685447010487 | VersaCross Connect Transseptal Dilator | VXA12-85-35-WM-D0 | 2022-05-19 | |
| 00685447010531 | VersaCross Connect Transseptal Dilator | VXA12-85-35-WM-D1 | NA | 2022-05-19 |
| 00685447010159 | VersaCross Steerable Sheath | VST0007 | 2022-05-09 | |
| 00685447010166 | VersaCross Steerable Sheath | VST0009 | 2022-05-09 | |
| 00685447010173 | VersaCross Steerable Sheath | VST0011 | 2022-05-09 | |
| 00685447010180 | VersaCross Steerable Sheath | VST0013 | 2022-05-09 | |
| 00685447010197 | VersaCross Steerable Sheath | VST0015 | 2022-05-09 | |
| 00685447010203 | VersaCross Steerable Sheath | VST0017 | 2022-05-09 | |
| 00685447010456 | SureFlex Steerable Guiding Sheath | TSK0007 | 2022-05-09 | |
| 00685447010463 | SureFlex Steerable Guiding Sheath | TSK0009 | 2022-05-09 | |
| 00685447010470 | SureFlex Steerable Guiding Sheath | TSK0011 | 2022-05-09 | |
| 00685447005285 | TorFlex Transseptal Guiding Sheath | TF8-32-63-37 | 2021-11-01 | |
| 00685447005292 | TorFlex Transseptal Guiding Sheath | TF8-32-63-45 | 2021-11-01 | |
| 00685447005308 | TorFlex Transseptal Guiding Sheath | TF8-32-63-55 | 2021-11-01 | |
| 00685447005315 | TorFlex Transseptal Guiding Sheath | TF8-32-63-90 | 2021-11-01 | |
| 00685447005322 | TorFlex Transseptal Guiding Sheath | TF8-32-63-135 | 2021-11-01 | |
| 00685447005339 | TorFlex Transseptal Guiding Sheath | TF8-32-81-37 | 2021-11-01 |
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