Avalign
Microsurgical Case, w/latches, 2 levels, 4 pin mats/2 retainers, half hght accy a, short tray,color-gold, 10" x19.5" x 2.5"
5manufacturers in China registered for this device type
447catalogue 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 | 2021-11-03 |
| 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Length 0.11 to 31 in; width 0.187 to 31 in; width 1.5 to 29 mm; height 1.5 to 8 in; length 3 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM15-91216 | In distribution | |
| 1000-918-008 | Length 0.5 in | In distribution |
| VM81-4788 | In distribution | |
| 95-2000100107 | Width 10.5 in | In distribution |
| PR.20-5654 | Width 9 in | In distribution |
| VM81-4941 | In distribution | |
| SCS30418 | In distribution | |
| VM15101121 | In distribution | |
| SCS30812 | Width 9 in | In distribution |
| DL2234 | In distribution | |
| 2000-100-032 | Width 11 in | In distribution |
| VM15-21241 | In distribution | |
| 43-11-0156 | Length 5 in | In distribution |
| 2000-162-051 | Width 12 mm | In distribution |
| 2000-162-130 | Length 1.5 in | In distribution |
| 2000-162-018 | Length 1 in | In distribution |
| 95-2000100006 | Length 17.5 in | In distribution |
| VM81-2396 | Length 12 mm | In distribution |
| 00-1115M | Length 14.13 in | In distribution |
| 95-2000162016 | Length 1 in | In distribution |
| 2000-100-018 | Length 5.5 in | In distribution |
| 20043-006 | Width 7 mm | In distribution |
| 95-2000100079 | Length 4.9 in | In distribution |
| VM15-41221 | In distribution | |
| 2000-300-015 | Width 9.63 in | In distribution |
| 2000-300-016 | Length 9.5 in | In distribution |
| PR.30011-1 | Length 10.5 in | In distribution |
| 00-1080 | Width 10 in | In distribution |
| 2000-162-004 | Length 1.5 in | In distribution |
| G-ACCBX | Length 1 in | In distribution |
| 2000-100-004 | Length 4 in | In distribution |
| 18-3525 | Length 19.5 in | In distribution |
| 2000-162-022 | Length 1 in | In distribution |
| SP40375-3 | Width 5 mm | In distribution |
| 2000-162-023 | Width 10 mm | In distribution |
| 43-11-0108 | Width 13 mm | In distribution |
| PR.2000-162-011 | Width 19 mm | In distribution |
| 1000-1110-013 | Length 1.5 in | In distribution |
| 33-31020S | In distribution | |
| 2000-100-035 | Length 2.5 in | In distribution |
| MS3859-06 | Width 7 mm | In distribution |
| 1000-1110-007 | Length 1.5 in | In distribution |
| 95-2000100029 | Length 2 in | In distribution |
| 04-30105 | In distribution | |
| 2000-100-022 | Length 3.5 in | In distribution |
| 1000-1110-058 | In distribution | |
| 2000-162-052 | In distribution | |
| 2000-162-127 | Width 16 mm | In distribution |
| 95-2000162015 | Length 1 in | In distribution |
| M2000-100-034 | Length 27 in | In distribution |
| 1000-1110-018 | Length 1 in | In distribution |
| 00-1120F | Width 10.5 in | In distribution |
| 95-2000100024 | Width 10.5 in | In distribution |
| 2000-162-112 | Length 2 in | In distribution |
| 600620 | Width 1.115 in | In distribution |
| VM15102121 | In distribution | |
| SCS51523 | Width 11 in | In distribution |
| 00-1115F | Width 10.5 in | In distribution |
| 43-11-0055 | Width 2 mm | In distribution |
| 21-4022 | Width 10.5 in | In distribution |
| VM15103611 | In distribution | |
| 2000-162-006 | Width 7 mm | In distribution |
| 95-2000162007 | Width 10 mm | In distribution |
| PR.21-1006 | Length 1.5 in | In distribution |
| 95-2000162052 | Width 10 mm | In distribution |
| 95-2000162054 | Width 5 mm | In distribution |
| 00-1115 | Length 1.5 in | In distribution |
| 2000-162-122 | Length 1 in | In distribution |
| 30812 | Width 9 in | In distribution |
| 1000-1110-005 | Length 1.5 in | In distribution |
| 95-2000100017 | Length 27 in | In distribution |
| 95-2000100020 | Width 11 in | In distribution |
| 1000-1110-023 | Length 1.5 in | In distribution |
| 262030-L | Length 15 in | In distribution |
| 1000-1110-048 | Length 1 in | In distribution |
| 2000-100-027 | Length 3 in | In distribution |
| 1000-1110-019 | Length 1 in | In distribution |
| VM15-51211 | Length 9 in | In distribution |
| SCS31420-8 | In distribution | |
| 00-1180 | Width 10.5 in | In distribution |
| VM1521231B | Width 18 in | In distribution |
| VM15-71281 | In distribution | |
| 95-2000100014 | Length 15 in | In distribution |
| 811497 | Width 3.23 in | In distribution |
| 2000-162-114 | Length 1.75 in | In distribution |
| 1000-1110-016 | Width 4 mm | In distribution |
| DL2218 | Length 15 in | In distribution |
| DL2244 | Length 21.5 in | In distribution |
| 2000-162-011 | Width 19 mm | In distribution |
| MS3859-02 | Length 1.5 in | In distribution |
| 2000-162-042 | Width 10 mm | In distribution |
| NXS10021 | Length 3.13 in | In distribution |
| VM15105231 | In distribution | |
| 01-3705 | Length 8 in | In distribution |
| 95-2000100002 | Width 5 in | In distribution |
| 1000-1110-003 | Width 4 mm | In distribution |
| VM15-41216 | In distribution | |
| SCS30109 | Length 3 in | In distribution |
| 2000-162-124 | Length 1 in | In distribution |
| 95-2000100013 | Width 10 in | In distribution |
| 2000-162-098 | Length 5 in | In distribution |
| 2000-100-009 | Width 10.5 in | In distribution |
| 95-2000100005 | Length 20 in | In distribution |
| SCS31015-S | Width 10.5 in | In distribution |
| 260022-PM | Length 10.5 in | In distribution |
| SCS403758 | In distribution | |
| DL2242B | In distribution | |
| 2000-100-007 | Length 2.5 in | In distribution |
| 2000-162-005 | Length 1.5 in | In distribution |
| 262020 | Length 2.5 in | In distribution |
| 2000-162-108 | Length 1.5 in | In distribution |
| 18-3520 | Length 15 in | In distribution |
| VM15-71222 | Length 11 in | In distribution |
| VM1521231A | Height 2.5 in | In distribution |
| 2000-162-004 | In distribution | |
| 2000-162-021 | Length 1 in | In distribution |
| AT0242 | Width 10.5 in | In distribution |
| MS3859-19 | Width 7 mm | In distribution |
| 43-11-0113 | Width 25 mm | In distribution |
| 43-11-0158 | Width 0.312 in | In distribution |
| 10-0031 | Width 11 in | In distribution |
| 00-1155 | Length 10 in | In distribution |
| 2000-100-016 | Length 3.5 in | In distribution |
| MS3859-05 | Length 1.5 in | In distribution |
| 95-2000162014 | Length 1 in | In distribution |
| 2000-100-025 | Length 15 in | In distribution |
| 95-2000100004 | Width 9 in | In distribution |
| 1000-906-001 | Length 0.5 in | In distribution |
| 2000-100-014 | Length 15 in | In distribution |
| DL2212 | Width 10.5 in | In distribution |
| 95-2000300013 | Length 18 in | In distribution |
| 01-2032C | Width 11 in | In distribution |
| 95-2000100030 | Width 11 in | In distribution |
| 43-11-0077 | Length 1.5 in | In distribution |
| 2000-162-009 | Length 1.5 in | In distribution |
| 2000-100-011 | Width 3 in | In distribution |
| 95-2000162071 | Length 5 in | In distribution |
| SCS40300-6 | Width 7 mm | In distribution |
| MS3859-17 | Length 1 in | In distribution |
| 18-3505 | Width 10.5 in | In distribution |
| 2000-914-001 | Width 0.187 in | In distribution |
| MS3859-32 | Width 3 mm | In distribution |
| VM15104146 | In distribution | |
| VM15102636 | In distribution | |
| VM15-81211 | In distribution | |
| VM15-71211 | In distribution | |
| 2000-162-036 | Length 1.5 in | In distribution |
| 262030-S | Length 2.5 in | In distribution |
| VM15-31211 | Height 3.5 in | In distribution |
| 2000-162-054 | Width 10 mm | In distribution |
| 2000-162-043 | Width 12 mm | In distribution |
| VM1521271C | In distribution | |
| A121 | In distribution | |
| 00-1110 | Length 10 in | In distribution |
| MS3859-15 | Length 1 in | In distribution |
| VM15104646 | In distribution | |
| 2000-162-123 | Length 1 in | In distribution |
| 01-3707 | Width 11 in | In distribution |
| MS3859-30 | Width 12 mm | In distribution |
| DL2222 | Width 10.5 in | In distribution |
| 21-3014 | Length 14.13 in | In distribution |
| 43-11-0109 | Width 15 mm | In distribution |
| 2000-162-071 | Width 10 mm | In distribution |
| DL2231 | In distribution | |
| 2000-260-002 | Width 1.5 in | In distribution |
| DL2230 | In distribution | |
| 95-2000100019 | Length 2.5 in | In distribution |
| 95-2000100011 | Length 11 in | In distribution |
| 2000-300-026 | Length 18.25 in | In distribution |
| 2000-162-015 | In distribution | |
| DL2234 | In distribution | |
| 43-11-0079 | Width 13 mm | In distribution |
| SCS21000 | Width 1.5 in | In distribution |
| 2000-162-039 | Width 5 mm | In distribution |
| MS3859-01 | Length 1.5 in | In distribution |
| MS3859-20 | Width 10 mm | In distribution |
| 43-11-0063 | Length 1 in | In distribution |
| 20043-008 | Length 1.5 in | In distribution |
| 1000-1110-012 | Width 22 mm | In distribution |
| 21-0030 | Length 23 in | In distribution |
| 2000-162-048 | Width 6 mm | In distribution |
| SCS31010 | Width 10.5 in | In distribution |
| 261015-FM | Width 10.5 in | In distribution |
| 43-11-0114 | Width 3 mm | In distribution |
| SCS31015-L | In distribution | |
| 43-11-0157 | Length 0.5 in | In distribution |
| 20043-017 | In distribution | |
| SCS403006 | In distribution | |
| 261015DBL | In distribution | |
| 2000-162-012 | Length 1.5 in | In distribution |
| VM15105161 | In distribution | |
| PR.2000-100-007 | Width 10.5 in | In distribution |
| 2000-162-034 | Width 12 mm | In distribution |
| 2000-162-030 | Length 1 in | In distribution |
| 2000-100-079 | Length 4.9 in | In distribution |
| 1000-1110-071 | Width 10 mm | In distribution |
| DL2231 | Width 10 in | In distribution |
| 2000-100-026 | Length 5.5 in | In distribution |
| 2000-300-056 | In distribution | |
| SCS403752 | In distribution | |
| VM15-21246 | In distribution | |
| 2000-100-010 | Length 6 in | In distribution |
| 43-11-0083 | Width 10 mm | In distribution |
| 2000-162-020 | Length 1 in | In distribution |
| 77-30-2042 | Length 23 in | In distribution |
| 95-2000100008 | Length 10.5 in | In distribution |
| 2000-162-024 | In distribution | |
| MS1854-18 | Width 10.12 in | In distribution |
| 2000-162-121 | Width 10 mm | In distribution |
| VM15-41211 | In distribution | |
| VM15-21251 | Height 1.5 in | In distribution |
| 1000-1120-017 | Width 1.5 in | In distribution |
| 1000-1110-024 | Length 1.5 in | In distribution |
| 95-2000100027 | Width 9 in | In distribution |
| PR.2000-162-052 | Width 3 mm | In distribution |
| VM15102641 | In distribution | |
| 2000-162-041 | In distribution | |
| 00-1125F | Length 2.5 in | In distribution |
| VM15-07111 | In distribution | |
| PR.2000-162-056 | Width 3 mm | In distribution |
| 18-3510 | Width 10.5 in | In distribution |
| VM81-17018 | In distribution | |
| 04-40100 | In distribution | |
| SP40375-5 | Length 1.5 in | In distribution |
| 2000-300-056 | In distribution | |
| 2000-162-017 | Length 1 in | In distribution |
| 43-11-0056 | Width 3 mm | In distribution |
| 95-2000100009 | Width 10.5 in | In distribution |
| 1000-1110-050 | Length 1 in | In distribution |
| DL2230 | Length 2.5 in | In distribution |
| 70-8715C | Length 23 in | In distribution |
| VM15104626 | In distribution | |
| 95-2000162036 | Length 1.5 in | In distribution |
| VM15-41246 | In distribution | |
| 2000-100-105 | Length 26.8 in | In distribution |
| 2145-03-05 | In distribution | |
| 2000-100-086 | Length 1.5 in | In distribution |
| 2000-162-033 | Length 1 in | In distribution |
| 00-1250 | Width 9 in | In distribution |
| 2000-300-018 | Width 10.12 in | In distribution |
| 1000-1110-011 | Length 1.5 in | In distribution |
| 2000-162-016 | Length 1 in | In distribution |
| 31421 | Length 2.5 in | In distribution |
| 2000-162-062 | Length 3.38 in | In distribution |
| MS1854-09 | Width 11 in | In distribution |
| TENL9720 | In distribution | |
| 43-11-0066 | Length 1.5 in | In distribution |
| 43-11-0143 | Length 4.25 in | In distribution |
| 43-11-0106 | Width 10 mm | In distribution |
| SCS3142010 | Width 9.9 in | In distribution |
Showing 250 of 300 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 |
| 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 |
| 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.