Tearaway Introducer Kit
35 catalogue numbers from KIT-009-11, listed by Galt Medical Corp., United States, under Percutaneous Sheath Introducer Kit. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
35catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Galt Medical Corp., United States |
|---|---|
| FDA product code | OFL |
| Device type | Percutaneous Sheath Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-06 |
| Record revised | 2024-03-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Shipper box of 50, shelf box of 5 |
| Sizes | Catheter gauge 4 to 16 Fr |
| Distribution end date | 2021-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIT-009-11 | Catheter Gauge 11 Fr | In distribution |
| HMP-009-16 | Catheter Gauge 16 Fr | In distribution |
| KIT-064-09 | Catheter Gauge 9 Fr | In distribution |
| HMP-009-06 | Catheter Gauge 6 Fr | In distribution |
| HMP-009-08 | Catheter Gauge 8 Fr | In distribution |
| HMP-009-09 | Catheter Gauge 9 Fr | In distribution |
| KIT-064-11 | Catheter Gauge 11 Fr | In distribution |
| KIT-064-10 | Catheter Gauge 10 Fr | In distribution |
| KIT-064-12 | Catheter Gauge 12 Fr | In distribution |
| HMP-009-05 | Catheter Gauge 5 Fr | In distribution |
| HMP-009-12 | Catheter Gauge 12 Fr | In distribution |
| KIT-009-02 | Catheter Gauge 5 Fr | In distribution |
| KIT-009-03 | Catheter Gauge 6 Fr | In distribution |
| KIT-009-05 | Catheter Gauge 8 Fr | In distribution |
| HMP-009-07 | Catheter Gauge 7 Fr | In distribution |
| HMP-009-10 | Catheter Gauge 10 Fr | In distribution |
| KIT-064-07 | Catheter Gauge 7 Fr | In distribution |
| KIT-009-07 | Catheter Gauge 9 Fr | In distribution |
| KIT-064-08 | Catheter Gauge 8 Fr | In distribution |
| KIT-009-04 | Catheter Gauge 7 Fr | In distribution |
| KIT-064-06 | Catheter Gauge 6 Fr | In distribution |
| HMP-009-13 | Catheter Gauge 13 Fr | In distribution |
| HMP-009-11 | Catheter Gauge 11 Fr | In distribution |
| KIT-064-085 | Catheter Gauge 8.5 Fr | In distribution |
| HMP-009-14 | Catheter Gauge 14 Fr | In distribution |
| KIT-009-12 | Catheter Gauge 12 Fr | Withdrawn |
| KIT-009-16 | Catheter Gauge 15 Fr | Withdrawn |
| KIT-009-13 | Catheter Gauge 12.5 Fr | Withdrawn |
| KIT-009-08 | Catheter Gauge 9.5 Fr | Withdrawn |
| KIT-009-09 | Catheter Gauge 10 Fr | Withdrawn |
| KIT-009-10 | Catheter Gauge 10.5 Fr | Withdrawn |
| KIT-009-14 | Catheter Gauge 13 Fr | Withdrawn |
| KIT-009-15 | Catheter Gauge 14 Fr | Withdrawn |
| KIT-009-17 | Catheter Gauge 16 Fr | Withdrawn |
| KIT-009-01 | Catheter Gauge 4 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Micro-Introducer Kit | Galt Medical Corp. | 53 |
| Micro-Access Tearaway Introducer Kit | Galt Medical Corp. | 49 |
| Stiffen Micro-Introducer Kit | Galt Medical Corp. | 28 |
| Elite Transitionless Micro-Introducer Kit | Galt Medical Corp. | 24 |
| Valved Tearaway Kit | Galt Medical Corp. | 24 |
| Typenex Introducer Set | Typenex Medical, LLC | 23 |
| Transitionless Micro-Introducer Kit | Galt Medical Corp. | 20 |
| Transitionless Stiffen Micro-Introducer Kit | Galt Medical Corp. | 19 |
| Seamless™ | B. Braun Medical Inc. | 19 |
| Stradis | Stradis Healthcare | 16 |
| TVS LPA | Galt Medical Corp. | 13 |
| GaltStick Introducer Kit | Galt Medical Corp. | 13 |
Showing 12 of 40. All products under Percutaneous Sheath Introducer Kit
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-03-27 | Class II | Process control | Due to a potential open seal in the sterile barrier packaging. | 4,280 kits |
| 2025-03-27 | Class II | Process control | Due to a potential open seal in the sterile barrier packaging. | 490 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.