V. Mueller
V. Mueller MEDIUM OPTICARE DOUBLE SCOPE TRAY HOLDS TWO SCOPES 1-10MM IN DIAMETER & 15-1/2" IN LGTH 15.5X2.75X1.38" (394X70X35MM)
5manufacturers in China registered for this device type
174catalogue numbers in this listing
4510(k) clearances naming this product code
18recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-07 |
| Record revised | 2023-04-04 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 75 |
| Distribution end date | 2023-10-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R1980ST | Withdrawn | ||
| R1775 | Withdrawn | ||
| R1769-RED | Withdrawn | ||
| GP6-8700 | Withdrawn | ||
| R1769-GREEN | Withdrawn | ||
| CL1388-PURPLE | Withdrawn | ||
| CL1769-BLUE | Withdrawn | ||
| R1976ST | Withdrawn | ||
| CD0-3ST | Withdrawn | ||
| CD5-3B | Withdrawn | ||
| CD5-61B-GOLD | Withdrawn | ||
| R1827-8 | Withdrawn | ||
| R1845 | Withdrawn | ||
| GP2-3020 | Withdrawn | ||
| GP3-7110 | Withdrawn | ||
| SU2995-010 | Withdrawn | ||
| CL1388-GOLD | Withdrawn | ||
| R1769-BLACK | Withdrawn | ||
| SX2-1 | Withdrawn | ||
| GP2-3000 | Withdrawn | ||
| CD5-3C-BLUE | Withdrawn | ||
| R1956 | Withdrawn | ||
| CD1-5ST | Withdrawn | ||
| R1842-A | Withdrawn | ||
| GP3-3225 | Withdrawn | ||
| R1388-BLUE | Withdrawn | ||
| GP4-4000 | Withdrawn | ||
| R1388-PURPLE | Withdrawn | ||
| GP3-3200 | Withdrawn | ||
| R1943 | Withdrawn | ||
| GP3-3130 | Withdrawn | ||
| R1843-A | Withdrawn | ||
| BP5-2V | Withdrawn | ||
| CD5-3B-RED | Withdrawn | ||
| GP6-1800 | Withdrawn | ||
| BP5-2AS | Withdrawn | ||
| GP3-3210 | Withdrawn | ||
| R1388-GOLD | Withdrawn | ||
| R1978ST | Withdrawn | ||
| CD5-3C-BLACK | Withdrawn | ||
| GP1-7110 | Withdrawn | ||
| CD5-3C-GREEN | Withdrawn | ||
| R1972ST | Withdrawn | ||
| CL1769-BLACK | Withdrawn | ||
| GP1-4800 | Withdrawn | ||
| R1840-A | Withdrawn | ||
| GP2-2020 | Withdrawn | ||
| CD5-61C-PURPLE | Withdrawn | ||
| R1769-PURPLE | Withdrawn | ||
| R1769-GOLD | Withdrawn | ||
| CD5-61B-BLUE | Withdrawn | ||
| SX2972-8 | Withdrawn | ||
| CL1388-BLUE | Withdrawn | ||
| SU2981-003 | Withdrawn | ||
| R1942 | Withdrawn | ||
| CD5-61B-PURPLE | Withdrawn | ||
| GP2-1000 | Withdrawn | ||
| CD4-5ST | Withdrawn | ||
| GP2-3200 | Withdrawn | ||
| GP2-1025 | Withdrawn | ||
| R1769 | Withdrawn | ||
| GP1-3600 | Withdrawn | ||
| R1390 | Withdrawn | ||
| GP7-6000 | Withdrawn | ||
| CL1769-GOLD | Withdrawn | ||
| CD5-3B-PURPLE | Withdrawn | ||
| GP2-1100 | Withdrawn | ||
| GP5-1110 | Withdrawn | ||
| GP1-7120 | Withdrawn | ||
| R1776 | Withdrawn | ||
| CD2-4ST | Withdrawn | ||
| CD5-61C-GREEN | Withdrawn | ||
| AG2-1 | 150 | Withdrawn | |
| GP2-4020 | Withdrawn | ||
| GP6-1100 | Withdrawn | ||
| GP3-3170 | Withdrawn | ||
| CD5-61C-RED | Withdrawn | ||
| CD5-3B-BLACK | Withdrawn | ||
| GP4-2000 | Withdrawn | ||
| GP3-5130 | Withdrawn | ||
| GP3-3220 | Withdrawn | ||
| R1844 | Withdrawn | ||
| GP4-1130 | Withdrawn | ||
| R1944 | Withdrawn | ||
| GP2-1020 | Withdrawn | ||
| R1170 | Withdrawn | ||
| GP7-1250 | Withdrawn | ||
| CD1-4ST | Withdrawn | ||
| CD2-6ST | Withdrawn | ||
| R1926 | Withdrawn | ||
| R1986ST | Withdrawn | ||
| R1984ST | Withdrawn | ||
| SU2981-008 | Withdrawn | ||
| CD1-6ST | Withdrawn | ||
| GP3-3215 | Withdrawn | ||
| R1171 | Withdrawn | ||
| CD5-61B-RED | Withdrawn | ||
| R1941 | Withdrawn | ||
| CL1388-RED | Withdrawn | ||
| SU2981 | Withdrawn | ||
| CD5-3C-GOLD | Withdrawn | ||
| R1769-BLUE | Withdrawn | ||
| CD5-61C | Withdrawn | ||
| R1974ST | Withdrawn | ||
| R1122 | Withdrawn | ||
| GP2-2000 | Withdrawn | ||
| CD5-61ST | Withdrawn | ||
| GP3-3131 | Withdrawn | ||
| R1388-RED | Withdrawn | ||
| CD5-3B-BLUE | Withdrawn | ||
| BP5-4V | Withdrawn | ||
| CD5-61B-GREEN | Withdrawn | ||
| CD5-61C-GOLD | Withdrawn | ||
| GP2-4000 | Withdrawn | ||
| CD3-5ST | Withdrawn | ||
| SX2-5 | Withdrawn | ||
| SU2995-030 | Withdrawn | ||
| CD5-3C-PURPLE | Withdrawn | ||
| R1929 | Withdrawn | ||
| CD5-3C-RED | Withdrawn | ||
| SX2972-10 | Withdrawn | ||
| R1961 | Withdrawn | ||
| BP5-2A | Withdrawn | ||
| AU19070 | Withdrawn | ||
| R1389 | Withdrawn | ||
| R1846 | Withdrawn | ||
| GP4-1200 | Withdrawn | ||
| R1388 | Withdrawn | ||
| CD5-3ST | Withdrawn | ||
| R1928 | Withdrawn | ||
| BP5-4A | Withdrawn | ||
| GP4-3200 | Withdrawn | ||
| CL1769-GREEN | Withdrawn | ||
| GP6-1914 | Withdrawn | ||
| GP1-2700 | Withdrawn | ||
| CL1388-BLACK | Withdrawn | ||
| SU2995-020 | Withdrawn | ||
| GP1-7100 | Withdrawn | ||
| R1955 | Withdrawn | ||
| BP5-3V | Withdrawn | ||
| SU2981-002 | Withdrawn | ||
| SU2981-001 | Withdrawn | ||
| SX2-0 | Withdrawn | ||
| CD5-3B-GREEN | Withdrawn | ||
| R1841-A | Withdrawn | ||
| CL1769-PURPLE | Withdrawn | ||
| CD3-7ST | Withdrawn | ||
| CD5-61C-BLACK | Withdrawn | ||
| CD5-61C-BLUE | Withdrawn | ||
| CD3-6ST | Withdrawn | ||
| CL1769-RED | Withdrawn | ||
| CD2-8ST | Withdrawn | ||
| CD3-4ST | Withdrawn | ||
| CD5-61B-BLACK | Withdrawn | ||
| R1388-GREEN | Withdrawn | ||
| GP7-1200 | Withdrawn | ||
| SX2-2 | Withdrawn | ||
| CD5-3C | Withdrawn | ||
| R1388-BLACK | Withdrawn | ||
| GP6-1400 | Withdrawn | ||
| GP1-3700 | Withdrawn | ||
| R1982ST | Withdrawn | ||
| CL1388-GREEN | Withdrawn | ||
| CD5-61B | Withdrawn | ||
| CD4-3ST | Withdrawn | ||
| AU35705 | Withdrawn | ||
| GP3-1210 | Withdrawn | ||
| R1968ST | Withdrawn | ||
| R1774 | Withdrawn | ||
| CD0-4ST | Withdrawn | ||
| R1970ST | Withdrawn | ||
| CD2-5ST | Withdrawn | ||
| GP3-3180 | Withdrawn | ||
| CD5-3B-GOLD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| Medline | Medline Industries, Inc. | 162 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153554 | 2016-03-21 |
| K142529 | 2015-01-08 |
| K140850 | 2014-08-27 |
| K112535 | 2012-04-27 |
Recalls Naming This Product
17 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 334 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 1143 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 493 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 1132 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 259 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 319 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 510 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 265 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 16 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 308 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 451 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 318 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 50 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 895 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 483 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 562 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-09-26 | Class II | Under Investigation by firm | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. | 537 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-01-30 | Class II | Packaging change control | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. | 5,952 devices |
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.