InnoFine
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with |Mindray| 65EC10(EA,EB,EC,ED,HA), 65EB10EA, 6CV1(s,P), CB10-4(s,P,E,A), V10-4(s), V10-4B(s,P),…
Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with |Mindray| 65EC10(EA,EB,EC,ED,HA), 65EB10EA, 6CV1(s,P), CB10-4(s,P,E,A), V10-4(s), V10-4B(s,P), V11-3(E,s), V11-3B(E), V11-3W(s,E), E9-3, V11-3H(E,U,s); |Wisonic| EV10-4, EV11-3-H; |Landwind| EC4-9; |Samsung| EC4-9IS, EC4-9ES, ER4-9ES; |GE Healthcare| IC5-9; |VINNO| G4-9E, X4-9E, F4-9E; |Zoncare| 6E1CD ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.
4manufacturers in China registered for this device type
531catalogue 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 | Jingfang Precision Medical Device(Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | OIJ |
| Device type | Biopsy Needle Guide Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-27 |
| Record revised | 2025-02-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 50 to 86 °F; Special storage condition: Keep Away from Sunlight |
| Packaging | Pack of 24, pack of 20, pack of 10, pack of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DE-021 | In distribution | |
| JSM-366 | In distribution | |
| JSM-456 | In distribution | |
| DE-024 | In distribution | |
| DEK-042 | In distribution | |
| JEM-071 | In distribution | |
| JSM-098 | In distribution | |
| JSM-017 | In distribution | |
| JSM-054 | In distribution | |
| DE-017 | In distribution | |
| JSM-027 | In distribution | |
| JEM-020 | In distribution | |
| JSM-081 | In distribution | |
| DEK-034 | In distribution | |
| JEM-083 | In distribution | |
| JSM-003 | In distribution | |
| JEM-011 | In distribution | |
| JSM-119 | In distribution | |
| JSM-334 | In distribution | |
| JSM-154 | In distribution | |
| DEK-054 | In distribution | |
| JEM-028 | In distribution | |
| JSM-126 | In distribution | |
| JSM-100 | In distribution | |
| JSM-142 | In distribution | |
| JSM-210 | In distribution | |
| JEM-038 | In distribution | |
| JEM-051 | In distribution | |
| JEM-033 | In distribution | |
| JSM-261 | In distribution | |
| DEK-026 | In distribution | |
| JSM-010 | In distribution | |
| JEM-043 | In distribution | |
| JSM-162 | In distribution | |
| JSM-171 | In distribution | |
| JSM-169 | In distribution | |
| JSM-193 | In distribution | |
| JEM-052 | In distribution | |
| DE-018 | In distribution | |
| JSM-500 | In distribution | |
| JSP-010 | In distribution | |
| JSM-123 | In distribution | |
| DE-058 | In distribution | |
| JSM-165 | In distribution | |
| DGC-0101 | In distribution | |
| DEK-056 | In distribution | |
| JSM-039 | In distribution | |
| JSM-222 | In distribution | |
| JSM-166 | In distribution | |
| JEM-072 | In distribution | |
| DT-007 | In distribution | |
| DE-054 | In distribution | |
| JSM-037 | In distribution | |
| JEM-021 | In distribution | |
| DE-046 | In distribution | |
| JSM-350 | In distribution | |
| DEK-012 | In distribution | |
| JEM-091 | In distribution | |
| JSM-262 | In distribution | |
| JSM-326 | In distribution | |
| JSM-207 | In distribution | |
| JSM-073 | In distribution | |
| DEK-033 | In distribution | |
| JSM-086 | In distribution | |
| JSM-125 | In distribution | |
| DGC-01 | In distribution | |
| JSM-434 | In distribution | |
| DEK-029 | In distribution | |
| DEK-018 | In distribution | |
| JSM-433 | In distribution | |
| JSM-325 | In distribution | |
| JEM-054 | In distribution | |
| JSM-327 | In distribution | |
| JSM-032 | In distribution | |
| JSM-075 | In distribution | |
| JSM-173 | In distribution | |
| JSM-300 | In distribution | |
| DE-020 | In distribution | |
| JSM-128 | In distribution | |
| JSM-341 | In distribution | |
| DEK-005 | In distribution | |
| JSM-078 | In distribution | |
| JEM-097 | In distribution | |
| JEM-068 | In distribution | |
| JSM-045 | In distribution | |
| JSM-131 | In distribution | |
| JSM-431 | In distribution | |
| JEM-013 | In distribution | |
| JSM-231 | In distribution | |
| JSM-002 | In distribution | |
| JEM-015 | In distribution | |
| DE-007 | In distribution | |
| JEM-065 | In distribution | |
| JSM-389 | In distribution | |
| JSM-095 | In distribution | |
| JSM-182 | In distribution | |
| JSM-097 | In distribution | |
| JSM-040 | In distribution | |
| JEM-056 | In distribution | |
| JSM-091 | In distribution | |
| JEM-017 | In distribution | |
| JSM-031 | In distribution | |
| JSM-215 | In distribution | |
| DE-014 | In distribution | |
| DEK-032 | In distribution | |
| JSM-435 | In distribution | |
| JSM-023 | In distribution | |
| JEM-016 | In distribution | |
| DEK-002 | In distribution | |
| JEM-022 | In distribution | |
| DE-019 | In distribution | |
| JSM-313 | In distribution | |
| JSM-267 | In distribution | |
| JSM-374 | In distribution | |
| DEK-003 | In distribution | |
| DE-050 | In distribution | |
| JSM-217 | In distribution | |
| JEM-025 | In distribution | |
| DEK-015 | In distribution | |
| JSM-280 | In distribution | |
| JSM-063 | In distribution | |
| DEK-041 | In distribution | |
| DE-047 | In distribution | |
| DGC-0102 | In distribution | |
| DEK-014 | In distribution | |
| JSM-020 | In distribution | |
| JSM-314 | In distribution | |
| JSM-011 | In distribution | |
| DEK-019 | In distribution | |
| JSM-223 | In distribution | |
| JSM-143 | In distribution | |
| JSP-159 | In distribution | |
| JEM-057 | In distribution | |
| JEM-058 | In distribution | |
| JSM-200 | In distribution | |
| JSM-398 | In distribution | |
| JSM-117 | In distribution | |
| JSM-055 | In distribution | |
| JSM-283 | In distribution | |
| JSP-089 | In distribution | |
| DEK-004 | In distribution | |
| JSM-012 | In distribution | |
| JSM-041 | In distribution | |
| DE-041 | In distribution | |
| JSM-153 | In distribution | |
| JSM-189 | In distribution | |
| JSM-025 | In distribution | |
| JEM-040 | In distribution | |
| JSM-330 | In distribution | |
| JSM-269 | In distribution | |
| JSM-179 | In distribution | |
| JSM-461 | In distribution | |
| JSM-036 | In distribution | |
| JSM-048 | In distribution | |
| JSM-067 | In distribution | |
| DE-037 | In distribution | |
| DEK-045 | In distribution | |
| DE-008 | In distribution | |
| JSM-227 | In distribution | |
| DEK-051 | In distribution | |
| JSM-292 | In distribution | |
| JSM-218 | In distribution | |
| JSM-237 | In distribution | |
| JSM-019 | In distribution | |
| JSM-058 | In distribution | |
| JEM-046 | In distribution | |
| JEM-018 | In distribution | |
| JSM-152 | In distribution | |
| JEM-001 | In distribution | |
| JEM-003 | In distribution | |
| JSM-053 | In distribution | |
| JSM-293 | In distribution | |
| DE-016 | In distribution | |
| JSM-113 | In distribution | |
| JEM-045 | In distribution | |
| JSM-082 | In distribution | |
| JEM-008 | In distribution | |
| DE-013 | In distribution | |
| JSM-379 | In distribution | |
| DT-004 | In distribution | |
| JSM-110 | In distribution | |
| JSM-414 | In distribution | |
| JSM-085 | In distribution | |
| JEM-075 | In distribution | |
| DEK-037 | In distribution | |
| JEM-093 | In distribution | |
| JSM-049 | In distribution | |
| JEM-049 | In distribution | |
| JSM-033 | In distribution | |
| JSM-270 | In distribution | |
| JSM-009 | In distribution | |
| JSM-436 | In distribution | |
| DE-003 | In distribution | |
| DEK-050 | In distribution | |
| JSM-106 | In distribution | |
| JSM-174 | In distribution | |
| JSM-013 | In distribution | |
| JSM-062 | In distribution | |
| JEM-006 | In distribution | |
| JSM-157 | In distribution | |
| DE-042 | In distribution | |
| JEM-062 | In distribution | |
| DEK-036 | In distribution | |
| DE-044 | In distribution | |
| JSM-320 | In distribution | |
| DGCK-01 | In distribution | |
| JEM-002 | In distribution | |
| JSM-297 | In distribution | |
| JEM-095 | In distribution | |
| JSM-127 | In distribution | |
| JSM-205 | In distribution | |
| JSM-430 | In distribution | |
| JSM-251 | In distribution | |
| JSM-336 | In distribution | |
| JSM-159 | In distribution | |
| JSM-268 | In distribution | |
| JSM-358 | In distribution | |
| JEM-096 | In distribution | |
| JSM-107 | In distribution | |
| DE-022 | In distribution | |
| DGCK-1102 | In distribution | |
| DEK-049 | In distribution | |
| DE-038 | In distribution | |
| JSM-096 | In distribution | |
| JSM-147 | In distribution | |
| DE-005 | In distribution | |
| JSM-114 | In distribution | |
| JEM-069 | In distribution | |
| JSM-175 | In distribution | |
| JSM-164 | In distribution | |
| DEK-038 | In distribution | |
| JSM-105 | In distribution | |
| JSM-005 | In distribution | |
| JEM-009 | In distribution | |
| JSM-322 | In distribution | |
| JEM-053 | In distribution | |
| JSM-108 | In distribution | |
| JSM-057 | In distribution | |
| JEM-036 | In distribution | |
| JSP-079 | In distribution | |
| JSM-088 | In distribution | |
| JSM-035 | In distribution | |
| JSM-335 | In distribution | |
| DEK-027 | In distribution | |
| JSM-256 | In distribution | |
| JSM-494 | In distribution | |
| DT-006 | In distribution | |
| DE-026 | In distribution | |
| JSM-115 | In distribution | |
| JSM-043 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 70 |
| Hitachi | Hitachi, Ltd. | 57 |
| Mindray | Jingfang Precision Medical Device(Shenzhen) Co., Ltd. | 16 |
| Sheathes | Sheathing Technologies, Inc. | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 12 |
| 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.