SUTURE LOOP HI-FI
- Primary DI
- 20653405002083
- Brand
- SUTURE LOOP HI-FI
- Company
- Conmed Corporation
- Model
- HL201
- Catalog number
- HL201
- Device description
- SutureLoop Hi-Fi Suture 20 inch Loop (5 Metric) White/Blue, Hi-Fi Polyblend Suture, Curved Needle
- Published
- 2015-10-24
- 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#
conmed.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 |
|---|---|
| K100006 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20653405002083 | Package | GS1 | 12 | In Commercial Distribution |
| 10653405002086 | Primary | GS1 | 0 | |
| 00653405002089 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 20653405002083 | 20653405002083 | ||
| 10653405002086 | 10653405002086 | ||
| 00653405002089 | 00653405002089 | 653405002089 | 0653405002089 |
GMDN Terms#
| Term | Definition |
|---|---|
| Suturing unit, single-use | A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)237-0169 | CUSTOMER_SERVICE@CONMED.COM |
Regulatory Flags#
- DUNS number
- 071595540
- Device count
- 12
- 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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| 20653405990953 | GENESYS™ CrossFT™ | CFBC-6503R | CFBC-6503R | 2026-07-31 |
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| 10845854035559 | E9000 | E9015 | E9015 | 2026-03-24 |
| 20653405008559 | CONMED | 60-0824-001 | 60-0824-001 | 2016-09-24 |
| 30653405003230 | CONMED | 138011 | 138011 | 2016-09-24 |
| 30653405003247 | CONMED | 138012 | 138012 | 2016-09-24 |
| 30653405058230 | AER DEFENSE | 60-8084-001 | 60-8084-001 | 2016-09-24 |
| 30845854655492 | PlumeSafe® X5™ | PX5-1354-22 | PX5-1354-22 | 2026-07-23 |
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|---|---|---|---|---|
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