Cardinal Health
Sterile Needle Core Biopsy PK
4manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shenzhen Wisonic Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OIJ |
| Device type | Biopsy Needle Guide Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-21 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case, case of 20, case of 2, case of 24, case of 10, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41-7717A | In distribution | |
| SAN7IABOUD | In distribution | |
| SAN7IABOU2 | In distribution | |
| SNU43BSSPE | In distribution | |
| 32-3502A | In distribution | |
| SNU43BSSPF | In distribution | |
| SAN7IABOUE | In distribution | |
| SAN7IABOUC | In distribution | |
| PG7IABOU1 | In distribution | |
| 41-4352A | In distribution | |
| SAN7IABOU1 | In distribution | |
| PG7IABOUA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InnoFine | Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 531 |
| SonoScape | Sonoscape Medical Corp. | 70 |
| Hitachi | Hitachi, Ltd. | 57 |
| Mindray | Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 16 |
| Sheathes | Sheathing Technologies, Inc. | 14 |
| Sheathes3D | Sheathing Technologies, Inc. | 7 |
| iSR’obot Kit | Biobot Surgical Pte. Ltd. | 4 |
| NGB-007 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| NGB-011 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| NGB-022 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| NGB-018 Needle-guided Bracket | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 2 |
| Moving-Shot Guide | RF Medical Co., Ltd. | 2 |
Showing 12 of 45. All products under Biopsy Needle Guide Kit
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.