Word
Word Catheter Silicone Bartholin Gland Balloon
1manufacturer
1catalogue number
1510(k) clearance
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | KNA |
| Device type | Instrument, Manual, Specialized Obstetric-Gynecologic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G55442 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kirwan | Kirwan Surgical Products, LLC. | 33 |
| 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 |
Showing 12 of 19. All products under Instrument, Manual, Specialized Obstetric-Gynecologic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K884291 | 1988-12-08 |
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.