Stradis
Custom Dental KIT, Small SET UP Pack, Oral Surgery Pack
3manufacturers in China registered for this device type
147catalogue 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 | 2022-03-14 |
| Record revised | 2022-06-17 (version 8) |
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 |
| Packaging | Case of 10 |
| Distribution end date | 2023-02-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 41038DKS | In distribution | ||
| 40824RWS | In distribution | ||
| 41022NMP | In distribution | ||
| 40554MOS | In distribution | ||
| 40739BBS | In distribution | ||
| 41022NMPR2 | 10 | In distribution | |
| 40566SSI | Withdrawn | ||
| 40512MFS | Withdrawn | ||
| 40805JCS | Withdrawn | ||
| 40911FPI | Withdrawn | ||
| 40183SSS | Withdrawn | ||
| 40591SPS | Withdrawn | ||
| 40709KMS | Withdrawn | ||
| 40948RWS | Withdrawn | ||
| 40416JFS | Withdrawn | ||
| 40951DCS | Withdrawn | ||
| 40357DJS | Withdrawn | ||
| 40516SHS | Withdrawn | ||
| 41033CMS | Withdrawn | ||
| 40629EJS | Withdrawn | ||
| 40922BCS | Withdrawn | ||
| 40426KYS | Withdrawn | ||
| 40156NSDS | Withdrawn | ||
| 40838BMS | Withdrawn | ||
| 40563EP | Withdrawn | ||
| 40655UCLAP | Withdrawn | ||
| 40508SSS | Withdrawn | ||
| 40913SNS | Withdrawn | ||
| 40720SBS | Withdrawn | ||
| 40811CSS | Withdrawn | ||
| 40335MMS | Withdrawn | ||
| 41059JBS | Withdrawn | ||
| 40083SPS | Withdrawn | ||
| 40900YGS | Withdrawn | ||
| 40297HDB | Withdrawn | ||
| 40708PAS | Withdrawn | ||
| 40637TMS | Withdrawn | ||
| 41172LYP | Withdrawn | ||
| 40568SSIII | Withdrawn | ||
| 40901JUS | Withdrawn | ||
| 40144NYUS | Withdrawn | ||
| 41084RDP | Withdrawn | ||
| 40214NWS | Withdrawn | ||
| 41044JAS | Withdrawn | ||
| 40904ECMS | Withdrawn | ||
| 40631WDS | Withdrawn | ||
| 40954CLS | Withdrawn | ||
| 40695JDS | Withdrawn | ||
| 40928JKS | Withdrawn | ||
| 40404RBS | Withdrawn | ||
| 40043CTI | Withdrawn | ||
| 40488JPS | Withdrawn | ||
| 40298KIP | Withdrawn | ||
| 40071MSS | Withdrawn | ||
| 40492ASP | Withdrawn | ||
| 40676TLS | Withdrawn | ||
| 40117ACS | Withdrawn | ||
| 40490APS | Withdrawn | ||
| 40463UMS | Withdrawn | ||
| 40857LWHI | Withdrawn | ||
| 40749DMS | Withdrawn | ||
| 40732GAS | Withdrawn | ||
| 40479MBS | Withdrawn | ||
| 40478JTS | Withdrawn | ||
| 40577WLS | Withdrawn | ||
| 41012RIP | Withdrawn | ||
| 40974ADA | Withdrawn | ||
| 40202WKS | Withdrawn | ||
| 40703NZS | Withdrawn | ||
| 40903WDS | Withdrawn | ||
| 41137TDS | Withdrawn | ||
| 40026DSS | Withdrawn | ||
| 40412EPS | Withdrawn | ||
| 20177RPSS | Withdrawn | ||
| 40147KNS | Withdrawn | ||
| 40826BKS | Withdrawn | ||
| 40217SGS | Withdrawn | ||
| 40449DJS | Withdrawn | ||
| 40879SPWS | Withdrawn | ||
| 40115EBS | Withdrawn | ||
| 40407DBS | Withdrawn | ||
| 40050KDMS | Withdrawn | ||
| 41047AHS | Withdrawn | ||
| 40166JBS | Withdrawn | ||
| 40551TMS | Withdrawn | ||
| 40801MKSII | Withdrawn | ||
| 40450SMS | Withdrawn | ||
| 40164RWS | Withdrawn | ||
| 40111COS | Withdrawn | ||
| 40561BIP-NS | Withdrawn | ||
| 40483ANS | Withdrawn | ||
| 40521SGS | Withdrawn | ||
| 40862MFS | Withdrawn | ||
| 40877PMS | Withdrawn | ||
| 40161BLS | Withdrawn | ||
| 40077GDS | Withdrawn | ||
| 40408BPP | Withdrawn | ||
| 40519USC | Withdrawn | ||
| 40346MGS | Withdrawn | ||
| 40020UOI | Withdrawn | ||
| 40859PMS | Withdrawn | ||
| 40593DGS | Withdrawn | ||
| 40927BSP | Withdrawn | ||
| 40829BCS | Withdrawn | ||
| 40668JZS | Withdrawn | ||
| 40061OSAS | Withdrawn | ||
| 40347KGS | Withdrawn | ||
| 40186BMI | Withdrawn | ||
| 40174DHS | Withdrawn | ||
| 40560SDP | Withdrawn | ||
| 40602DGS | Withdrawn | ||
| 40885SBS | Withdrawn | ||
| 41076HOS | Withdrawn | ||
| 40788SMS | Withdrawn | ||
| 40125DCI | Withdrawn | ||
| 40330BGS | Withdrawn | ||
| 40704ABW | Withdrawn | ||
| 40363SLS | Withdrawn | ||
| 40668JZS | Withdrawn | ||
| 40816GFS | Withdrawn | ||
| 40300GCS | Withdrawn | ||
| 40472PID | Withdrawn | ||
| 40916KCS | Withdrawn | ||
| 40023HSP | Withdrawn | ||
| 40402MNS | Withdrawn | ||
| 40564GCS | Withdrawn | ||
| 40706MSS | Withdrawn | ||
| 40407DBS | Withdrawn | ||
| 40280OSA | Withdrawn | ||
| 40210MMI | Withdrawn | ||
| 40916KCS | Withdrawn | ||
| 40258GYS | Withdrawn | ||
| 40809SIP | Withdrawn | ||
| 40547KKS | Withdrawn | ||
| 40420PKS | Withdrawn | ||
| 40908NOS | Withdrawn | ||
| 40259RPS | Withdrawn | ||
| 40561BIP | Withdrawn | ||
| 41172LYP | Withdrawn | ||
| 41022NMPR2 | Withdrawn | ||
| 40969AKS | Withdrawn | ||
| 40580DFS | Withdrawn | ||
| 40784DES | Withdrawn | ||
| 40551TMS | Withdrawn | ||
| 40426KYS | Withdrawn | ||
| 40610APS | Withdrawn | ||
| 40543DMS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stradis Healthcare | Stradis Healthcare | 215 |
| 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
6 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. | 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. | 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. | 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. | 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. | 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.