Nipro Safetouch™ II Gamma Safety Fistula Needle
18Gx1-1/4" Fixed Hub 11" Tubing
4manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Nipro Medical Corporation, United States |
|---|---|
| FDA product code | FIE |
| Device type | Needle, Fistula |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Complaint-file establishment, Exporter |
| Record published | 2019-09-18 |
| Record revised | 2018-12-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, box of 50, carton of 50 |
| Sizes | Length 1.25 in; needle gauge 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18G X 1-1/4″ | Length 1.25 in | In distribution |
| 17GX1-1/4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medisystems Hemodialysis Fistula Needle Set with MasterGuard | Medisystems Corp. | 72 |
| Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard | Medisystems Corp. | 44 |
| masterguard plus Hemodialysis Fistula Needle SET | Nxstage Medical, Inc. | 35 |
| masterguard plus Twinpack+ Hemodialysis Fistula Needle Sets | Nxstage Medical, Inc. | 20 |
| Dora | Bain Medical Equipment(Guangzhou) Co., Ltd. | 17 |
| JMS Wingeater A.v.fistula Needle SET | JMS Singapore PTE. Ltd | 15 |
| Medisystems Button Hole Needle Set | Medisystems Corp. | 14 |
| ButtonHole with SteriPick Twinpack+ Needle SET | Nxstage Medical, Inc. | 14 |
| Medisystems TwinPack ButtonHole Needle Set with SteriPick | Medisystems Corp. | 14 |
| ButtonHole with SteriPick Needle SET | Nxstage Medical, Inc. | 14 |
| Medisystems Button Hole Needle Set with SteriPick | Medisystems Corp. | 14 |
| JMS A.V. Fistula Needle SET | JMS Singapore PTE. Ltd | 11 |
Showing 12 of 32. All products under Needle, Fistula
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100520 | 2010-03-17 |
| K093985 | 2010-01-22 |
| K063368 | 2007-02-05 |
| K063721 | 2007-01-12 |
| K002813 | 2000-11-21 |
| K991623 | 1999-08-09 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2002-11-08 | Not classified | Other | Air or fluid leakage at the hub/needle junction. | 6,984,000 | 2008-04-15 |
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.