Millennium
Scope case 2 level w/o brackets 9"x20"x4" External Size: 9" x 20" x 4". Two level. Without brackets, dividers. (OPTIONAL BRACKETS 4each #95-2000162054 & 4each item #95-2000162056)
5manufacturers in China registered for this device type
268catalogue numbers in this listing
1510(k) clearance
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 | Avalign Technologies, 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 | Specification developer, Manufacturer |
| Record published | 2017-05-22 |
| Record revised | 2023-07-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 10.5 in; width 10.5 in; height 2.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2000-162-025 | In distribution | |
| 95-2000300056 | In distribution | |
| NL9720 | In distribution | |
| 2000-100-101 | In distribution | |
| 2000-100-020C | In distribution | |
| 95-2000162015 | In distribution | |
| 95-2000162014 | In distribution | |
| 95-2000300010 | In distribution | |
| 18-TH110 | In distribution | |
| 2000-100-030 | In distribution | |
| 2000-300-003 | In distribution | |
| 95-2000100024 | In distribution | |
| 2000-162-100 | In distribution | |
| 2000-162-029 | In distribution | |
| 2000-162-019 | In distribution | |
| 2000-100-024 | In distribution | |
| 2000-300-025 | In distribution | |
| 95-2000300018 | In distribution | |
| 2000-162-032 | In distribution | |
| 95-2000100027 | In distribution | |
| 95-2000100029 | In distribution | |
| 95-2000162003 | In distribution | |
| 95-2000162054 | In distribution | |
| 2000-300-015 | In distribution | |
| 2000-914-001 | In distribution | |
| 9-59720 | In distribution | |
| 2000-300-019 | In distribution | |
| 95-2000100003 | In distribution | |
| 95-2000100013 | In distribution | |
| 95-2000100022 | In distribution | |
| 95-2000100009 | In distribution | |
| 2000-162-049 | In distribution | |
| 2000-100-012 | In distribution | |
| 95-2000162030 | In distribution | |
| 2000-300-024 | In distribution | |
| 95-2000100023 | In distribution | |
| 2000-100-027 | In distribution | |
| 2000-162-115 | In distribution | |
| 2000-162-030 | In distribution | |
| 95-2000162016 | In distribution | |
| 2000-100-013 | In distribution | |
| 95-2000162003 | In distribution | |
| 2000-162-022 | In distribution | |
| 95-2000100004 | In distribution | |
| 2000-100-025 | In distribution | |
| CH9210-008 | In distribution | |
| 2000-100-078 | In distribution | |
| 95-2000100010 | In distribution | |
| 2000-300-007 | In distribution | |
| 2000-202-024 | In distribution | |
| 2000-300-001 | In distribution | |
| 25-1020 | In distribution | |
| 95-2000100007 | Length 10.5 in | In distribution |
| 2000-500-001 | In distribution | |
| 1000-906-001 | In distribution | |
| 95-2000162008 | In distribution | |
| 95-2000100026 | In distribution | |
| 2000-100-106 | In distribution | |
| 2000-162-116 | In distribution | |
| 95-2000162009 | In distribution | |
| 2000-300-010 | In distribution | |
| 2000-162-020 | In distribution | |
| 2000-162-044 | In distribution | |
| 95-2000100036 | In distribution | |
| 95-2000100031 | In distribution | |
| 95-2000300015 | In distribution | |
| 2000-100-022 | In distribution | |
| 95-2000100013 | In distribution | |
| 95-2000300026 | In distribution | |
| 2000-100-120 | In distribution | |
| 2000-204-022 | In distribution | |
| 2000-100-021 | In distribution | |
| 2000-100-016 | In distribution | |
| 95-2000162056 | In distribution | |
| 2000-162-066 | In distribution | |
| 95-2000162018 | In distribution | |
| 2000-300-016 | In distribution | |
| 2000-300-023 | In distribution | |
| 95-2000162062 | In distribution | |
| 95-2000100053 | In distribution | |
| 2000-300-018 | In distribution | |
| 95-2000162064 | In distribution | |
| 2000-162-043 | In distribution | |
| 2000-162-064 | In distribution | |
| 95-2000100020 | In distribution | |
| 95-2000300012 | In distribution | |
| 2000-300-022 | In distribution | |
| 95-2000100004 | In distribution | |
| 2000-162-067 | In distribution | |
| 95-2000100006 | In distribution | |
| 2000-162-027 | In distribution | |
| 2000-162-010 | In distribution | |
| 95-2000-100-053 | In distribution | |
| 2000-162-046 | In distribution | |
| 95-2000100031 | In distribution | |
| 95-2000100079 | In distribution | |
| 2000-300-005 | In distribution | |
| 2000-162-040 | In distribution | |
| 95-2000100020 | In distribution | |
| 10-250095 | In distribution | |
| 95-2000100021 | In distribution | |
| 2000-100-011 | In distribution | |
| 2000-162-056 | In distribution | |
| 2000-162-058 | In distribution | |
| 2000-100-102 | In distribution | |
| 95-2000100016 | In distribution | |
| 2000-300-017 | In distribution | |
| 2000-100-017 | In distribution | |
| 95-2000162017 | In distribution | |
| 95-2000100106 | In distribution | |
| 95-2000100007 | In distribution | |
| 95-2000100013 | In distribution | |
| 2000-162-045 | In distribution | |
| 2000-162-002 | In distribution | |
| 95-2000162024 | In distribution | |
| 95-2000100018 | In distribution | |
| 2000-162-028 | In distribution | |
| 95-2000162017 | In distribution | |
| 95-2000100014 | In distribution | |
| 95-2000100012 | In distribution | |
| 95-2000100035 | In distribution | |
| 2000-100-086 | In distribution | |
| 2000-100-002 | In distribution | |
| 25-1006 | In distribution | |
| 2000-162-004 | In distribution | |
| 2000-162-012 | In distribution | |
| 2000-162-054 | In distribution | |
| 2000-162-098 | In distribution | |
| 95-2000100032 | In distribution | |
| 2000-162-041 | In distribution | |
| 95-2000100020C | In distribution | |
| 2000-162-052 | In distribution | |
| 95-2000100009 | In distribution | |
| 2000-162-071 | In distribution | |
| 2000-162-048 | In distribution | |
| 2000-100-114 | In distribution | |
| 95-2000100024 | In distribution | |
| 2000-162-011 | In distribution | |
| 2000-100-086 | In distribution | |
| 2000-300-009 | In distribution | |
| 2000-162-023 | In distribution | |
| 2000-162-035 | In distribution | |
| 2000-300-026 | In distribution | |
| 95-2000300018 | In distribution | |
| 95-2000162071 | In distribution | |
| 1100-924-001 | In distribution | |
| 2000-300-020 | In distribution | |
| 2000-162-114 | In distribution | |
| 95-2000300013 | In distribution | |
| 95-2000162066 | In distribution | |
| 95-2000100006 | In distribution | |
| 2000-100-014 | In distribution | |
| 95-2000162063 | In distribution | |
| 95-2000100015 | In distribution | |
| 2000-300-014 | In distribution | |
| 95-2000100106 | In distribution | |
| 95-2000100053 | In distribution | |
| 95-2000162010 | In distribution | |
| 95-2000162013 | In distribution | |
| 95-2000100017 | In distribution | |
| 2000-162-009 | In distribution | |
| 25-1015 | In distribution | |
| 25-1010 | In distribution | |
| 95-2000100017 | In distribution | |
| 95-2000100007 | In distribution | |
| 2000-162-026 | In distribution | |
| 10-117114-MAT | In distribution | |
| 2000-162-107 | In distribution | |
| 95-2000100012 | In distribution | |
| 2000-300-006 | In distribution | |
| 2000-162-037 | In distribution | |
| 2000-100-007 | In distribution | |
| 95-2000100030 | In distribution | |
| 2000-300-004 | In distribution | |
| 2000-162-013 | In distribution | |
| 95-2000162015 | In distribution | |
| 95-2000100003 | In distribution | |
| 2000-100-025 | In distribution | |
| 2000-162-038 | In distribution | |
| 95-2000100002 | In distribution | |
| 2000-162-006 | In distribution | |
| 95-2000162-010 | In distribution | |
| 95-2000100001 | In distribution | |
| 95-2000162007 | In distribution | |
| 2000-100-079 | In distribution | |
| 95-2000100002 | In distribution | |
| 2000-162-108 | In distribution | |
| 2000-100-034 | In distribution | |
| 95-2000100079 | In distribution | |
| 2000-100-107 | In distribution | |
| 95-2000100029 | In distribution | |
| 117-144 | In distribution | |
| 95-2000100027 | In distribution | |
| 95-2000100107 | In distribution | |
| 95-2000162030 | In distribution | |
| 95-2000100005 | In distribution | |
| 95-2000100010 | In distribution | |
| 2000-162-055 | In distribution | |
| 2000-162-050 | In distribution | |
| 95-2000162052 | In distribution | |
| 95-2000100030 | In distribution | |
| 95-2000162002 | In distribution | |
| 2000-100-104 | In distribution | |
| 95-2000162047 | In distribution | |
| 2000-300-008 | In distribution | |
| 2000-100-036 | In distribution | |
| 95-2000204022 | In distribution | |
| 95-2000100027 | In distribution | |
| 95-20000162016 | In distribution | |
| 95-2000162011 | In distribution | |
| 95-2000162058 | In distribution | |
| 2000-162-021 | In distribution | |
| 2000-162-034 | In distribution | |
| 95-2000300056 | In distribution | |
| 2000-100-105 | In distribution | |
| 2000-162-110 | In distribution | |
| 95-2000162023 | In distribution | |
| 95-2000100011 | In distribution | |
| 2000-162-042 | In distribution | |
| 1000-918-008 | In distribution | |
| 95-2000100008 | In distribution | |
| 95-2000100034 | In distribution | |
| 2000-100-109 | In distribution | |
| 95-2000162007 | In distribution | |
| 95-2000100025 | In distribution | |
| 2000-162-031 | In distribution | |
| 95-2000162020 | In distribution | |
| 95-31015L | In distribution | |
| 2000-100-010 | In distribution | |
| 95-2000100001 | In distribution | |
| 95-2000100014 | In distribution | |
| 2000-162-018 | In distribution | |
| 95-2000100019 | In distribution | |
| 2000-100-035 | In distribution | |
| 2000-162-118 | In distribution | |
| 95-2000100008 | In distribution | |
| 95-2000100002 | In distribution | |
| 95-2000100009 | In distribution | |
| 95-2000100020 | In distribution | |
| 2000-260-002 | In distribution | |
| 2000-300-013 | In distribution | |
| 95-2000100032 | In distribution | |
| 2000-162-047 | In distribution | |
| 2000-300-002 | In distribution | |
| 2000-300-011 | In distribution | |
| 2000-162-036 | In distribution | |
| 2000-100-026 | In distribution | |
| 2000-162-063 | In distribution | |
| 2000-162-062 | In distribution | |
| 2000-162-008 | In distribution |
Showing 250 of 268 catalogue numbers.
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 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
| 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 |
|---|---|
| K193066 | 2020-08-06 |
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.