| Primary Device ID | 00841912103591 |
| NIH Device Record Key | f8af493b-1fed-490d-9bb9-4adaa2fd7562 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biopsy Starter Kit |
| Version Model Number | 7350 |
| Company DUNS | 965417181 |
| Company Name | PROTEK MEDICAL PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841912103591 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
[00841912103591]
High-level Disinfectant
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 8 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-09-16 |
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| 00841912103768 | Biopsy Starter Kit for Samsung Medison LN5-12 & LE5-12 Ultrasound Transducers |
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| 00841912103676 | Single Angle Stainless Steel Biopsy Starter Kit for Philips C7-3 Ultrasound Transducers |
| 00841912103652 | Single Angle Biopsy Starter Kit for Philips C5-2 Ultrasound Transducers |
| 00841912103645 | Biopsy Starter Kit for Esaote LA522E/LA532E/LA523/LA523E/LA523P Ultrasound Transducers |
| 00841912103638 | Biopsy Starter Kit for Esaote CA 123, 15° Ultrasound Transducers |
| 00841912103621 | Biopsy Starter Kit for Esaote CA621/CA631 Ultrasound Transducers |
| 00841912103614 | Biopsy Starter Kit for Esaote CA421/CA430/CA431 Ultrasound Transducers |
| 00841912103607 | Biopsy Starter Kit for Esaote LA522E/LA532E/LA523/LA523E/LA523P, 45° Ultrasound Transducers |
| 00841912103591 | Biopsy Starter Kit for Esaote LA 424/435, 45° Ultrasound Transducers |
| 00841912103553 | Single Angle Biopsy Starter Kit for Samsung Medison C2-6IC Ultrasound Transducers |
| 00841912103461 | Biopsy Starter Kit for Ultrasonix L14-5/38 & L9-38 Ultrasound Transducers |
| 00841912103454 | Single Angle Stainless Steel Biopsy Starter Kit for Samsung Medison C2-5 Ultrasound Transducers |
| 00841912103447 | Single Angle Biopsy Starter Kit for Samsung Medison C2-5 Ultrasound Transducers |
| 00841912103430 | Single Angle Biopsy Starter Kit for Samsung Medison C3-7EP Ultrasound Transducers |
| 00841912103423 | Single Angle Biopsy Starter Kit for Samsung Medison L5-12/40EP Ultrasound Transducers |
| 00841912103416 | Single Angle Biopsy Starter Kit for Samsung Medison C2-5EP Ultrasound Transducers |
| 00841912103409 | Single Angle Biopsy Starter Kit for Samsung Medison HL5-12ED Ultrasound Transducers |
| 00841912103393 | Biopsy Starter Kit for Samsung Medison L5-12/50EP Ultrasound Transducers |
| 00841912103386 | Biopsy Starter Kit for Terason 4C2-V & Vermon CLA3.5 Ultrasound Transducers |
| 00841912103379 | Biopsy Starter Kit for Samsung Medison 3DC2-6 Ultrasound Transducers |
| 00841912103362 | Biopsy Starter Kit for Samsung Medison C2-5ET Ultrasound Transducers |
| 00841912103348 | Biopsy Starter Kit for Ultrasonix L14-5/38 & L9-4/38 Ultrasound Transducers |
| 00841912106295 | Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers |
| 00841912106134 | Biopsy Starter Kit for Terason 12L5, 15L4, 10L5 & Vermon L7 Ultrasound Transducers |
| 00841912106479 | Biopsy Starter Kit for Mindray C5-1s, C5-1U, SC6-1s & SC6-1U Ultrasound Transducers |
| 00841912106431 | Biopsy Starter Kit for Mindray L9-3U Ultrasound Transducers |
| 00841912106448 | Biopsy Starter Kit for Mindray L14-5w & L14-5WU Ultrasound Transducers |
| 00841912106639 | Single Angle Biopsy Starter Kit for Samsung Medison CN2-8 Ultrasound Transducers |
| 00841912106158 | Biopsy Starter Kit for Terason 15L4A & 15l4 Smart Mark Ultrasound Transducers |
| 00841912106189 | Biopsy Starter Kit for Hitachi L64 Ultrasound Transducers |
| 00841912106103 | Biopsy Starter Kit for GE 4C, 4C-A, 4C-D, 4C-RS, 4C-SC & 5CS Ultrasound Transducers |
| 00841912106097 | Biopsy Starter Kit for Mindray C4-1 and Zonare C4-1 Ultrasound Transducers |
| 00841912106172 | Biopsy Starter Kit for Mindray C5-2E & C5-2s Ultrasound Transducers |
| 00841912106240 | Biopsy Starter Kit for Canon-Toshiba PLI-1205BX (i18LX5) Ultrasound Transducers |
| 00841912106721 | Biopsy Starter Kit for Sonosite C60, C60e & C60x Ultrasound Transducers |
| 00841912106677 | Biopsy Starter Kit for Mindray SC8-2U Ultrasound Transducers |