Kirwan
Reusable Titanium BP Frcps, 2 3/4" WL, Mark "DUAL-0.5S" on Cup, Add Dual Irr. 0.032 Irr. Tube Surface Mounted on Handle but Buried in WL, 2 Stops Grooved to Interlock with an Irr. Tube When…
Reusable Titanium BP Frcps, 2 3/4″ WL, Mark “DUAL-0.5S” on Cup, Add Dual Irr. 0.032 Irr. Tube Surface Mounted on Handle but Buried in WL, 2 Stops Grooved to Interlock with an Irr. Tube When Closed. (Special)
1manufacturer
33catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
Record
| Listed by | Kirwan Surgical Products, LLC., United States |
|---|---|
| FDA product code | KNA |
| Device type | Instrument, Manual, Specialized Obstetric-Gynecologic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Manufacturer |
| 510(k) | K844823 |
| Record published | 2019-01-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 10.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-5302NSS | In distribution | |
| 15-5110S | In distribution | |
| 15-5102S | In distribution | |
| 15-5402AUS | In distribution | |
| 15-5401AUS | In distribution | |
| 15-5301S | In distribution | |
| 15-5102S | In distribution | |
| 15-5102S | In distribution | |
| 15-5303S | In distribution | |
| 15-5101S | In distribution | |
| 15-5302S | In distribution | |
| 15-5303S | In distribution | |
| 15-5301S | In distribution | |
| 15-5301S | In distribution | |
| 15-5302S | Length 10.75 in | In distribution |
| 15-5302S | Length 10.75 in | In distribution |
| 15-5302S | In distribution | |
| 15-5302NSS | In distribution | |
| 15-5303S | In distribution | |
| 15-5303S | In distribution | |
| 15-5402AUS | In distribution | |
| 15-5104S | In distribution | |
| 15-5102S | Length 10.75 in | In distribution |
| 15-5402AUS | In distribution | |
| 15-5303S | In distribution | |
| 15-5402AUS | In distribution | |
| 15-5402AUS | In distribution | |
| 15-5103S | In distribution | |
| 15-5303S | Length 10.75 in | In distribution |
| 15-1437AUS | In distribution | |
| 15-5102S | Length 10.75 in | In distribution |
| 15-5103S | In distribution | |
| 15-5401AUS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 15 |
| Centurion | Centurion Medical Products Corporation | 14 |
| Cyst Puncture Needle with Stylet | Vitrolife Sweden AB | 12 |
| Cyst Puncture Needle without Stylet | Vitrolife Sweden AB | 7 |
| Alexis ® O C-Section Protector-Retractor | Applied Medical Resources Corp. | 4 |
| Tenacath | Cook Incorporated | 2 |
| Bioteque | Bioteque Taiwan Ltd. | 2 |
| Obstetrical Kit | Dynarex Corp. | 2 |
| Cook | Cook Incorporated | 2 |
| Pro-Ception | Coopersurgical, Inc. | 2 |
| Gynex | Gynex Corporation | 1 |
| Cordguard® | Utah Medical Products, Inc. | 1 |
Showing 12 of 19. All products under Instrument, Manual, Specialized Obstetric-Gynecologic
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.