| Primary Device ID | 00615233078100 | 
| NIH Device Record Key | fbd69293-3d4f-4f2d-8cce-839aba8f6719 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Tissue-Tek® | 
| Version Model Number | 4163 | 
| Catalog Number | 4163 | 
| Company DUNS | 179135769 | 
| Company Name | SAKURA FINETEK U.S.A., INC. | 
| Device Count | 1 | 
| DM Exempt | true | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +1(310)972-7800 | 
| TS@sakuraus.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00615233078100 [Primary] | 
| KER | CONTAINER, EMBEDDING | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-01-02 | 
| Device Publish Date | 2019-12-25 | 
| 14560133242171 | Coverslipping Film | 
| 10615233078657 | O.C.T. Compound | 
| 10615233013887 | Mold Release | 
| 10615233078282 | Processing/Embedding Cassettes, White | 
| 10615233078275 | Processing/Embedding Cassettes, Blue | 
| 10615233078268 | Processing/Embedding Cassettes, Green | 
| 10615233078251 | Processing/Embedding Cassettes, Pink | 
| 10615233078220 | Processing/Embedding Cassettes, Yellow | 
| 10615233013825 | Processing/Embedding Cassette, Aqua | 
| 10615233013818 | Processing/Embedding Cassette, Gold | 
| 10615233013801 | Processing/Embedding Cassette, Lilac | 
| 10615233013795 | Processing/Embedding Cassette, Orange | 
| 10615233013788 | Processing/Embedding Cassette, Tan | 
| 00615233082220 | Processing/Embedding Stacked Cassettes, White | 
| 00615233082213 | Processing/Embedding Stacked Cassettes, Blue | 
| 00615233082206 | Processing/Embedding Stacked Cassettes, Green | 
| 00615233082190 | Processing/Embedding Stacked Cassettes, Pink | 
| 00615233082176 | Processing/Embedding Stacked Cassettes, Yellow | 
| 00615233082077 | Processing/Embedding Stacked Cassettes, Aqua | 
| 00615233082060 | Processing/Embedding Stacked Cassettes, Gold | 
| 00615233082053 | Processing/Embedding Stacked Cassettes, Lilac | 
| 00615233082046 | Processing/Embedding Stacked Cassettes, Orange | 
| 00615233082039 | Processing/Embedding Stacked Cassettes, Tan | 
| 10615233078602 | 24 - Slide Holder with Handle | 
| 10615233078312 | Processing/Embedding Cassette, Clear | 
| 00615233078599 | Staining Dish, White with lid | 
| 00615233078582 | Staining Dish, Green with lid | 
| 00615233078575 | Manual Slide Staining Set | 
| 00615233078322 | Cassette Cabinet | 
| 00615233013897 | Embedding Ring, White | 
| 00615233013651 | Embedding Ring, Blue | 
| 00615233013644 | Embedding Ring, Green | 
| 00615233013637 | Embedding Ring, Pink | 
| 00615233013620 | Embedding Ring, Yellow | 
| 00615233078339 | Processing/Embedding Cassette Cover | 
| 10615233078688 | Waste Collection Bags | 
| 10615233078664 | Cold Plate | 
| 00615233080837 | Barcode Reader System for Coverslippers | 
| 00615233078407 | Biopsy Bags, Medium (4.5 x 6.5 cm); 500/box | 
| 00615233078391 | Biopsy Bags, Small (3 x 5 cm); 1,000/box | 
| 00615233078124 | Base Mold 37 x 24 x 5 mm | 
| 00615233078117 | Base Mold 30 x 24 x 5 mm | 
| 00615233078100 | Base Mold 24 x 24 x 5 mm | 
| 00615233078094 | Base Mold 15 x 15 x 5 mm | 
| 00615233078087 | Base Mold 7 x 7 x 5 mm | 
| 00615233013859 | Base Mold for Embedding Rings 38 x 25 x 12 mm | 
| 00615233013842 | Base Mold for Embedding Rings 32 x 25 x 12 mm | 
| 00615233013835 | Base Mold for Embedding Rings 22 x 22 x 12 mm | 
| 00615233013774 | Base Mold for Embedding Rings 38 x 25 x 6 mm | 
| 00615233013767 | Base Mold for Embedding Rings 32 x 25 x 6 mm | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TISSUE-TEK  72084436  0743380 Live/Registered | LAB-TEK PLASTICS CO. 1959-11-02 |