Temno Evolution
Temno Evolution Needle Biposy 20G X 15CM
3manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-30 |
| Record revised | 2023-10-12 (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, manufacturing date |
| Packaging | Case of 5 |
| Sizes | Needle gauge 14 to 20 G; length 6 to 20 cm |
| Distribution end date | 2019-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TT2015 | Needle Gauge 20 G | Withdrawn |
| TT2020 | Length 20 cm | Withdrawn |
| TT2011 | Length 11 cm | Withdrawn |
| CTT1611 | Length 11 cm | Withdrawn |
| TT1611 | Length 11 cm | Withdrawn |
| CTT1420 | Needle Gauge 14 G | Withdrawn |
| CTT1615 | Length 15 cm | Withdrawn |
| CTT1411 | Needle Gauge 14 G | Withdrawn |
| CTT2015 | Length 15 cm | Withdrawn |
| TT206 | Needle Gauge 20 G | Withdrawn |
| CTT1811 | Needle Gauge 18 G | Withdrawn |
| CTT2020 | Length 20 cm | Withdrawn |
| CTT1820 | Length 20 cm | Withdrawn |
| TT186 | Needle Gauge 18 G | Withdrawn |
| TT1811 | Length 11 cm | Withdrawn |
| CTT1815 | Needle Gauge 18 G | Withdrawn |
| TT1815 | Length 15 cm | Withdrawn |
| CTT1415 | Needle Gauge 14 G | Withdrawn |
| CTT1620 | Length 20 cm | Withdrawn |
| TT1820 | Needle Gauge 18 G | Withdrawn |
| CTT2011 | Length 11 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
Showing 12 of 115. All products under Biopsy Needle
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.