Stradis Healthcare
Custom Convenience KIT, Plastic Surgery KIT - Implant Pack
3manufacturers in China registered for this device type
215catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | PWL |
| Device type | Oral Surgery Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-03-10 |
| Record revised | 2023-02-01 (version 6) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 6, case of 5, case of 10, case of 4, case of 8, case of 25 |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40508SSS | In distribution | |
| 40269PLS | In distribution | |
| 40925GHS | In distribution | |
| 40186BMI | In distribution | |
| ZZ-1411 | In distribution | |
| 41206TSSP | In distribution | |
| 40877PMS | In distribution | |
| 570-2683 | In distribution | |
| 40839EGS | In distribution | |
| 41111UTI | In distribution | |
| 40420PKS | In distribution | |
| 40560SDP | In distribution | |
| 40932RTS | In distribution | |
| 41022NMP | In distribution | |
| 40582UNC | In distribution | |
| 40806UMP | In distribution | |
| 40149SSS | In distribution | |
| 40811CSS | In distribution | |
| 40356RTS | In distribution | |
| 40953SRC | In distribution | |
| 40657JGS | In distribution | |
| 40826BKS | In distribution | |
| 20177RPSS | In distribution | |
| 40573JMS | In distribution | |
| 41240AMSP | Withdrawn | |
| 40298KIP | Withdrawn | |
| 40276BDS | Withdrawn | |
| 41236SDSP | Withdrawn | |
| 570-2915 | Withdrawn | |
| 40547KKS | Withdrawn | |
| 41047AHS | Withdrawn | |
| 40561BIP-NS | Withdrawn | |
| 41126CBS | Withdrawn | |
| 40851JCS | Withdrawn | |
| 41152UMS | Withdrawn | |
| 41181PIP | Withdrawn | |
| 40902SSS | Withdrawn | |
| 30190MIDP | Withdrawn | |
| 40914JKS R1 | Withdrawn | |
| 41035FLS | Withdrawn | |
| 40602DGS | Withdrawn | |
| 40275PAS | Withdrawn | |
| 40841EAS | Withdrawn | |
| 40562HNP | Withdrawn | |
| 41139GSP | Withdrawn | |
| 40966SCV | Withdrawn | |
| 40789YCS | Withdrawn | |
| 40161BLS | Withdrawn | |
| 40063LBS | Withdrawn | |
| 41001MDC | Withdrawn | |
| 40115EBS | Withdrawn | |
| 40869WHS | Withdrawn | |
| 003-3144 | Withdrawn | |
| 40561BIP | Withdrawn | |
| 40357DJS | Withdrawn | |
| 41074BNSII | Withdrawn | |
| 40283PASII | Withdrawn | |
| 40838BMS | Withdrawn | |
| 40669SKS | Withdrawn | |
| 570-2612 | Withdrawn | |
| 40894DGS | Withdrawn | |
| 40202WKS | Withdrawn | |
| 41062JSS | Withdrawn | |
| 40092MWS | Withdrawn | |
| 41084RDP | Withdrawn | |
| 41237HASP | Withdrawn | |
| 40144NYUS | Withdrawn | |
| 40150AGS | Withdrawn | |
| 41112UTIL | Withdrawn | |
| 40363SLS | Withdrawn | |
| 40992BHS | Withdrawn | |
| 40416JFS | Withdrawn | |
| 40636UPI | Withdrawn | |
| 41205SSP | Withdrawn | |
| 40310SBI | Withdrawn | |
| 40208AMS | Withdrawn | |
| 40631WDS | Withdrawn | |
| 40463UMS | Withdrawn | |
| 570-2218 | Withdrawn | |
| 40111COS | Withdrawn | |
| 40166JBS | Withdrawn | |
| 41231UPOP | Withdrawn | |
| 41124ECU | Withdrawn | |
| 40404RBS | Withdrawn | |
| 40809SIP | Withdrawn | |
| 41213ATCP | Withdrawn | |
| 40020UOI | Withdrawn | |
| 40494TRS | Withdrawn | |
| 41201ADIP | Withdrawn | |
| 40913SNS | Withdrawn | |
| 40743PPSII | Withdrawn | |
| 40125DCI | Withdrawn | |
| 40023HSP | Withdrawn | |
| 40522BPS | Withdrawn | |
| 40943MKS | Withdrawn | |
| 40554MOS | Withdrawn | |
| 40346MGS | Withdrawn | |
| 40962GCI | Withdrawn | |
| 40922BCS | Withdrawn | |
| 41012RIP | Withdrawn | |
| 40863TDS | Withdrawn | |
| 40374KKS | Withdrawn | |
| 40721FIP | Withdrawn | |
| 40496AHS | Withdrawn | |
| 40295POS | Withdrawn | |
| 40702WAS | Withdrawn | |
| 40810ECS | Withdrawn | |
| 40742PPSI | Withdrawn | |
| 40793MLS | Withdrawn | |
| 40300GCS | Withdrawn | |
| 40241HIS | Withdrawn | |
| 40043CTI | Withdrawn | |
| 41037RLS | Withdrawn | |
| 40923LFS | Withdrawn | |
| 40259RPS | Withdrawn | |
| 40591SPS | Withdrawn | |
| 40466WGS | Withdrawn | |
| 40519USC | Withdrawn | |
| 682-1899 | Withdrawn | |
| 40969AKS | Withdrawn | |
| 40297HDB | Withdrawn | |
| 41018RSP | Withdrawn | |
| 40996WLS | Withdrawn | |
| 40584MPS | Withdrawn | |
| 40017MCS | Withdrawn | |
| 40222SRS | Withdrawn | |
| 40911FPI | Withdrawn | |
| 41238GDCP | Withdrawn | |
| 40214NWS | Withdrawn | |
| 40106JRS | Withdrawn | |
| 40376DGS | Withdrawn | |
| 40903WDS | Withdrawn | |
| 40577WLS | Withdrawn | |
| 40919UCLA | Withdrawn | |
| 003-3143 | Withdrawn | |
| 40967VSS | Withdrawn | |
| 41010KJS | Withdrawn | |
| 41251MMDP | Withdrawn | |
| 41256CDGP | Withdrawn | |
| 41233CDNY | Withdrawn | |
| 40518VPS | Withdrawn | |
| 40334POSR1 | Withdrawn | |
| 40844HCPI | Withdrawn | |
| 41021RKS | Withdrawn | |
| 40510TWS | Withdrawn | |
| 41057LCP | Withdrawn | |
| 40294CSS | Withdrawn | |
| 40210MMI | Withdrawn | |
| 40335MMS | Withdrawn | |
| 40105RMS | Withdrawn | |
| 40580DFS | Withdrawn | |
| 40951DCS | Withdrawn | |
| 40853FSFP | Withdrawn | |
| 40862MFS | Withdrawn | |
| 40512MFS | Withdrawn | |
| 40654MRS | Withdrawn | |
| 40685JYS | Withdrawn | |
| 40883UCP | Withdrawn | |
| 40228MMSR1 | Withdrawn | |
| 40568SSIII | Withdrawn | |
| 40638GHBS | Withdrawn | |
| 40319AIP | Withdrawn | |
| 40567SSII | Withdrawn | |
| 40732GAS | Withdrawn | |
| 40085GTI | Withdrawn | |
| 40321OMSA | Withdrawn | |
| 40347KGS | Withdrawn | |
| 40071MSS | Withdrawn | |
| 40351AKS | Withdrawn | |
| 40907SRII | Withdrawn | |
| 41243LDSP | Withdrawn | |
| 40121MWI | Withdrawn | |
| 40974ADA | Withdrawn | |
| 40756LSS | Withdrawn | |
| 41241SCSP | Withdrawn | |
| 40490APS | Withdrawn | |
| 41077TSP | Withdrawn | |
| 40807SCP | Withdrawn | |
| 40952SRB | Withdrawn | |
| 003-3891 | Withdrawn | |
| 003-3880 | Withdrawn | |
| 40026DSS | Withdrawn | |
| 40963BCP | Withdrawn | |
| 40492ASP | Withdrawn | |
| 003-4823 | Withdrawn | |
| 40147KNS | Withdrawn | |
| 40472PID | Withdrawn | |
| 41239MWSP | Withdrawn | |
| 40879SPWS | Withdrawn | |
| 40639GHBSF | Withdrawn | |
| 41197MCDS | Withdrawn | |
| 40904ECMS | Withdrawn | |
| 40885SBS | Withdrawn | |
| 40084MKS | Withdrawn | |
| 40521SGS | Withdrawn | |
| 40174DHS | Withdrawn | |
| 41143MCP | Withdrawn | |
| 41137TDS | Withdrawn | |
| 40488JPS | Withdrawn | |
| 40201GBS | Withdrawn | |
| 40950HSP | Withdrawn | |
| 40610APS | Withdrawn | |
| 40649ECS | Withdrawn | |
| 41254CDCP | Withdrawn | |
| 40258GYS | Withdrawn | |
| 40050KDMS | Withdrawn | |
| 687-553 | Withdrawn | |
| 41190DAMB | Withdrawn | |
| 40943MKS | Withdrawn | |
| 41101ACP | Withdrawn | |
| 41209CDSP | Withdrawn | |
| 40110MNS | Withdrawn | |
| 40233SBS | Withdrawn | |
| 41257MIDP | Withdrawn | |
| 687-607 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stradis | Stradis Healthcare | 147 |
| Invenio | GRI-Alleset, Inc. | 58 |
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| Henry Schein | Henry Schein, Inc. | 5 |
| Patient Pack NSU V2 | Stradis Healthcare | 1 |
| Stradis Medical, LLC. | Stradis Healthcare | 1 |
| Hiossen Simple Instrument KIT | Osstem Implant Co., Ltd. | 1 |
| Hiossen Basic Instrument KIT | Osstem Implant Co., Ltd. | 1 |
| Surgical Room | Stradis Healthcare | 1 |
| Instrapac | Robinson Healthcare Limited | 1 |
Recalls Naming This Product
10 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. | 10 kits |
| 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. | 25 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. | 80 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. | 20 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. | 180 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. | 20 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. | 12 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. | 20 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.