Stradis
Custom Convenience KIT, Plastic Surgery KIT - Implant Pack
13manufacturers in China registered for this device type
305catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| FDC Technology Industry Company | Taishan,Guang Chong | Guangdong | Manufacturer | 6 |
| Foshan Gladent Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 6 |
| Sinol Dental Limited | Xianyang | Shaanxi | Manufacturer | 5 |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Guangdong Yadeng Medical Apparatus Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Mipont Medical Equipment Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
| Foshan Safety Medical Equipment Co., Ltd. | China | Guangdong | Manufacturer | 1 |
| Shanghai Fimet Medical Instrument Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Unit, Operative Dental
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | EIA |
| Device type | Unit, Operative Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Record published | 2016-07-01 |
| Record revised | 2022-06-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40884MWFD | In distribution | |
| 40648TOFS | In distribution | |
| 40238GGS | In distribution | |
| 40956CUS | In distribution | |
| 40748JGS1 | In distribution | |
| 40796SWS | In distribution | |
| 40514SMS | In distribution | |
| 40415PSP | In distribution | |
| 40870LCS | In distribution | |
| 40116TCS | In distribution | |
| 40330BGS | In distribution | |
| 40459MTS | In distribution | |
| 40835JMS | In distribution | |
| 40615RFS | In distribution | |
| 40052GBS | In distribution | |
| 20173WLD | In distribution | |
| 41080BHD | In distribution | |
| 40207BES | In distribution | |
| 40808PPB | In distribution | |
| 40700RFS | In distribution | |
| 40622UNCP | In distribution | |
| 20115CIR | In distribution | |
| 40397HSDMS | In distribution | |
| 40093DGS | In distribution | |
| 40533PGS | In distribution | |
| 40469RWS | In distribution | |
| 40124AWI | In distribution | |
| 40435MZS | In distribution | |
| 40353KNS | In distribution | |
| 40920MRS | In distribution | |
| 40422LSP | In distribution | |
| 40232TNS | In distribution | |
| 41048MWU | In distribution | |
| 41061NLS | In distribution | |
| 40497AUS | In distribution | |
| 40334POS | In distribution | |
| 40911FRI | In distribution | |
| 40840UWE | In distribution | |
| 20090CIH | In distribution | |
| 20208MMH | In distribution | |
| 40433NSS | In distribution | |
| 40405RDS | In distribution | |
| 40148CNS | In distribution | |
| 40002GGP | In distribution | |
| 682-077 | In distribution | |
| 40633JMS | In distribution | |
| 40231DFS | In distribution | |
| 20133KRO | In distribution | |
| 40457NSS | In distribution | |
| 40609SFS | In distribution | |
| 40220SSP | In distribution | |
| 40528DGS | In distribution | |
| 40449DJS | In distribution | |
| 40678UMKC | In distribution | |
| 40979KWS | In distribution | |
| 41056ABS | In distribution | |
| 40944TLS | In distribution | |
| 40866CJS | In distribution | |
| 40616PKS | In distribution | |
| 41026MCS | In distribution | |
| 41003MSP | In distribution | |
| 40555MMS | In distribution | |
| 40897WES | In distribution | |
| 40914JKS | In distribution | |
| 20065HET | In distribution | |
| 40675ARS | In distribution | |
| 40534AMS | Withdrawn | |
| 40582UNC | Withdrawn | |
| 41034RHS | Withdrawn | |
| 20268CLFH | Withdrawn | |
| 40853FSFP | Withdrawn | |
| 40394BUOSCS | Withdrawn | |
| 20150DSH | Withdrawn | |
| 20116OMH | Withdrawn | |
| 41015NSI | Withdrawn | |
| 20273CDP | Withdrawn | |
| 30037DCO | Withdrawn | |
| 40201GBS | Withdrawn | |
| 40953SRC | Withdrawn | |
| 40471MKP | Withdrawn | |
| 40702WAS | Withdrawn | |
| 40692SYK | Withdrawn | |
| 40806UMP | Withdrawn | |
| 40228MMS | Withdrawn | |
| 40017mcs | Withdrawn | |
| 40410DFS | Withdrawn | |
| 20022JRHII | Withdrawn | |
| 40914JKS | Withdrawn | |
| 40932RTS | Withdrawn | |
| 40068FKS | Withdrawn | |
| 40592OMS | Withdrawn | |
| 40771GPS | Withdrawn | |
| 41067BFO | Withdrawn | |
| 20117TOD | Withdrawn | |
| 40586RCS | Withdrawn | |
| 40393BUOS | Withdrawn | |
| 40410DFS | Withdrawn | |
| 40910DKS | Withdrawn | |
| 30023bdd | Withdrawn | |
| 20254SPP | Withdrawn | |
| 40084MKS | Withdrawn | |
| 20052BFH | Withdrawn | |
| 40079DBS | Withdrawn | |
| 20004JHH | Withdrawn | |
| 40554MOS | Withdrawn | |
| 20153RBD | Withdrawn | |
| 41198NRD | Withdrawn | |
| 40105RMS | Withdrawn | |
| 40548IUS | Withdrawn | |
| 40234DSI | Withdrawn | |
| 40063LBS | Withdrawn | |
| 40394BUOSCS | Withdrawn | |
| 40826TMS | Withdrawn | |
| 40756LSS | Withdrawn | |
| 40469RWS | Withdrawn | |
| 40222SRS | Withdrawn | |
| 30024BDH | Withdrawn | |
| 40748JGS1 | Withdrawn | |
| 40184WCS | Withdrawn | |
| 40940RSS | Withdrawn | |
| 40208AMS | Withdrawn | |
| 40863TDS | Withdrawn | |
| 20263MTP | Withdrawn | |
| 41037RLS | Withdrawn | |
| 40636UPI | Withdrawn | |
| 40399WADAS | Withdrawn | |
| 41151LDP | Withdrawn | |
| 41022NMP | Withdrawn | |
| 20118ODH | Withdrawn | |
| 40108LPS | Withdrawn | |
| 40846MKS | Withdrawn | |
| 40326ROS | Withdrawn | |
| 40510TWS | Withdrawn | |
| 40894DGS | Withdrawn | |
| 40851JCS | Withdrawn | |
| 40921SMS | Withdrawn | |
| 689-337 | Withdrawn | |
| 40412EPS | Withdrawn | |
| 40184WCS | Withdrawn | |
| 20081ECD | Withdrawn | |
| 40242RHS | Withdrawn | |
| 40657JGS | Withdrawn | |
| 40669SKS | Withdrawn | |
| 40257CJS | Withdrawn | |
| 40771GPS | Withdrawn | |
| 20048BSR | Withdrawn | |
| 40695JDS | Withdrawn | |
| 40703NZS | Withdrawn | |
| 40031JHS | Withdrawn | |
| 41044JAS | Withdrawn | |
| 40283PASII | Withdrawn | |
| 40804DGSS | Withdrawn | |
| 40110MNS | Withdrawn | |
| 30185MCCC | Withdrawn | |
| 30061ABT | Withdrawn | |
| 40584MPS | Withdrawn | |
| 41015NSI | Withdrawn | |
| 40923LFS | Withdrawn | |
| 40554MOS | Withdrawn | |
| ORALSURG | Withdrawn | |
| 40739BBS | Withdrawn | |
| 40894DGS | Withdrawn | |
| 40494TRS | Withdrawn | |
| 41106CSP | Withdrawn | |
| 40047MWS | Withdrawn | |
| 40639GHBSF | Withdrawn | |
| 40283PASII | Withdrawn | |
| 40522BPS | Withdrawn | |
| 935K | Withdrawn | |
| 40803DGI | Withdrawn | |
| 40863TDS | Withdrawn | |
| 41060DAS | Withdrawn | |
| 20114JVH | Withdrawn | |
| 40275PAS | Withdrawn | |
| 20093SND | Withdrawn | |
| 20174WLH | Withdrawn | |
| 40849JLS | Withdrawn | |
| 40214NWS | Withdrawn | |
| 40233SBS | Withdrawn | |
| 20113JVD | Withdrawn | |
| 41073BNS | Withdrawn | |
| 20059PED | Withdrawn | |
| 30023BDD | Withdrawn | |
| 40638GHBS | Withdrawn | |
| 40801MKSII | Withdrawn | |
| 40494TRS | Withdrawn | |
| 41022NMP | Withdrawn | |
| 30084BBH | Withdrawn | |
| 40376DGS | Withdrawn | |
| 40756LSS | Withdrawn | |
| 20031THJD | Withdrawn | |
| 20273CDP | Withdrawn | |
| 20061RHD | Withdrawn | |
| 20168GJDT | Withdrawn | |
| 40759MMS | Withdrawn | |
| 40771GPS | Withdrawn | |
| 40084MKS | Withdrawn | |
| 20172GJLG | Withdrawn | |
| 40839EGS | Withdrawn | |
| 41072SSP | Withdrawn | |
| 30248CGTH | Withdrawn | |
| 41074BNSII | Withdrawn | |
| 40894DGS | Withdrawn | |
| 40788SMS | Withdrawn | |
| 20149DSD | Withdrawn | |
| 41171AFD | Withdrawn | |
| 30036DCH | Withdrawn | |
| 20053BFO | Withdrawn | |
| 40374KKS | Withdrawn | |
| 40566SSI | Withdrawn | |
| 41004GLD | Withdrawn | |
| 40824RWS | Withdrawn | |
| 40714IES | Withdrawn | |
| 40150AGS | Withdrawn | |
| 40420PKS | Withdrawn | |
| 40319AIP | Withdrawn | |
| 40385FTS | Withdrawn | |
| 40295POS | Withdrawn | |
| 20113JVD | Withdrawn | |
| 40742PPSI | Withdrawn | |
| 40374KKS | Withdrawn | |
| 40771GPS | Withdrawn | |
| 20172GJLG | Withdrawn | |
| 40562HNP | Withdrawn | |
| 40356RTS | Withdrawn | |
| 40784DES | Withdrawn | |
| 40294CSS | Withdrawn | |
| 40351AKS | Withdrawn | |
| 40104SCS | Withdrawn | |
| 40031JHS | Withdrawn | |
| 41017NSP | Withdrawn | |
| 41099CGP | Withdrawn | |
| 20169GOG | Withdrawn | |
| 40017MCS | Withdrawn | |
| 41038DKS | Withdrawn | |
| 40105RMS | Withdrawn | |
| 20003ABD | Withdrawn | |
| 40756LSS | Withdrawn | |
| 40234DSI | Withdrawn | |
| 20167LBP | Withdrawn | |
| 40743PPSII | Withdrawn | |
| 41088CSP | Withdrawn | |
| 40573JMS | Withdrawn | |
| 40901JUS | Withdrawn | |
| 40925GHS | Withdrawn | |
| 40343USS | Withdrawn | |
| 40046OSG | Withdrawn | |
| 40800PLSS | Withdrawn | |
| 40318FDCS | Withdrawn | |
| 30019MAFO | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Forest | Ls Enterprises, Inc. | 285 |
| DCI | DCI International, LLC | 201 |
| DCI Edge | DCI International, LLC | 149 |
| A-dec | A-dec, Inc. | 66 |
| Aseptico | Aseptico, Inc. | 29 |
| Midmark | Midmark Corporation | 27 |
| Unit, Operative Dental | Ergonomic Products, Inc. | 20 |
| TPS | Stryker GmbH | 20 |
| Evogue Dental Unit | Takara Belmont Corporation | 20 |
| Belmont X-Calibur Unit | Takara Belmont Corporation | 19 |
| Dentacenter Operative Dental Unit | Safari Dentaire Inc | 12 |
| Unit, Operative Dental | Stryker GmbH | 11 |
Showing 12 of 224. All products under Unit, Operative Dental
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 18 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 18 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 6 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 30 units |
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.