Integra® Miltex®
Integra® Miltex® Varady Phlebectomy Extractors, Set of 6 (Ref #'S 10305, 10306, 10307, 10308, 10309, 10310)
3manufacturers in China registered for this device type
44catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GAI |
| Device type | Stripper, Vein, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-10-23 |
| Record revised | 2023-04-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Length 5 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10310 | 6-3/4″ Length | In distribution |
| 10372 | 6-1/2″ | In distribution |
| 10412 | In distribution | |
| 10334 | 5-1/4″ | In distribution |
| 1033 | In distribution | |
| 10305 | 7″ Length | In distribution |
| 10361 | In distribution | |
| 10333 | Length 5 in | In distribution |
| 10324 | In distribution | |
| 10409 | In distribution | |
| 10351 | In distribution | |
| 10383 | 6-1/2″ | In distribution |
| 1040 | In distribution | |
| 10410 | In distribution | |
| 10332 | 4-7/8″ | In distribution |
| 10382 | 6-1/2″ | In distribution |
| 1035 | In distribution | |
| 10371 | 6-1/2″ | In distribution |
| 10362 | In distribution | |
| 10321 | In distribution | |
| 10322 | In distribution | |
| 10308 | 6-3/4″ Length | In distribution |
| 10404 | In distribution | |
| 10331 | 4-3/4″ | In distribution |
| 1032 | In distribution | |
| 1036 | In distribution | |
| 10403 | In distribution | |
| 10323 | In distribution | |
| 10407 | In distribution | |
| 10352 | In distribution | |
| 10408 | In distribution | |
| 10306 | 7″ Length | In distribution |
| 10307 | In distribution | |
| 10373 | 6-1/2″ | In distribution |
| 10405 | In distribution | |
| 1037 | In distribution | |
| 1038 | In distribution | |
| 10-291 | In distribution | |
| 10406 | In distribution | |
| 10381 | 6-1/2″ | In distribution |
| 10411 | In distribution | |
| 10309 | 6-3/4″ Length | In distribution |
| 10-290 | In distribution | |
| 1030 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atramat | Internacional Farmacéutica S.A DE C.V | 44 |
| Sklar® | Sklar Corporation | 41 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 39 |
| Surtex | Surtex Instruments Ltd | 17 |
| Aesculap | Aesculap AG | 17 |
| Stripper | KLS-Martin L.P. | 9 |
| Millennium | Avalign Technologies, Inc. | 9 |
| Hayden Medical | Hayden Medical Inc | 6 |
| V. Mueller | Steris Corporation | 6 |
| BR Surgical, LLC | BR Surgical LLC | 5 |
| HNM Medical | HNM Stainless, LLC. | 4 |
| V. Mueller | Carefusion 2200, Inc. | 4 |
Showing 12 of 24. All products under Stripper, Vein, Reusable
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.