| Primary Device ID | 08809763509438 | 
| NIH Device Record Key | ac737e92-8df9-41cf-bf2d-5923a1ab9510 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | INNESIS PEEK TL CAGE | 
| Version Model Number | 52845-09 | 
| Company DUNS | 687941818 | 
| Company Name | BK MEDITECH CO.,LTD. | 
| Device Count | 1 | 
| DM Exempt | false | 
| 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 | true | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08809763509438 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
[08809763509438]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-06-22 | 
| Device Publish Date | 2023-06-14 | 
| 08809228124404 | PEEK Cage, L32 x W12 x H15mm, 4° | 
| 08809228124398 | PEEK Cage, L32 x W12 x H14mm, 4° | 
| 08809228124381 | PEEK Cage, L32 x W12 x H13mm, 4° | 
| 08809228124374 | PEEK Cage, L32 x W12 x H12mm, 4° | 
| 08809228124367 | PEEK Cage, L32 x W12 x H11mm, 4° | 
| 08809228124350 | PEEK Cage, L32 x W12 x H10mm, 4° | 
| 08809228124343 | PEEK Cage, L32 x W12 x H9mm, 4° | 
| 08809228124336 | PEEK Cage, L32 x W12 x H8mm, 4° | 
| 08809228124329 | PEEK Cage, L32 x W12 x H7mm, 4° | 
| 08809228124312 | PEEK Cage, L28 x W10 x H15mm, 4° | 
| 08809228124305 | PEEK Cage, L28 x W10 x H14mm, 4° | 
| 08809228124299 | PEEK Cage, L28 x W10 x H13mm, 4° | 
| 08809228124282 | PEEK Cage, L28 x W10 x H12mm, 4° | 
| 08809228124275 | PEEK Cage, L28 x W10 x H11mm, 4° | 
| 08809228124268 | PEEK Cage, L28 x W10 x H10mm, 4° | 
| 08809228124251 | PEEK Cage, L28 x W10 x H9mm, 4° | 
| 08809228124244 | PEEK Cage, L28 x W10 x H8mm, 4° | 
| 08809228124237 | PEEK Cage, L28 x W10 x H7mm, 4° | 
| 08809228124220 | PEEK Cage, L32 x W12 x H15mm, 0° | 
| 08809228124213 | PEEK Cage, L32 x W12 x H14mm, 0° | 
| 08809228124206 | PEEK Cage, L32 x W12 x H13mm, 0° | 
| 08809228124190 | PEEK Cage, L32 x W12 x H12mm, 0° | 
| 08809228124183 | PEEK Cage, L32 x W12 x H11mm, 0° | 
| 08809228124176 | PEEK Cage, L32 x W12 x H10mm, 0° | 
| 08809228124169 | PEEK Cage, L32 x W12 x H9mm, 0° | 
| 08809228124152 | PEEK Cage, L32 x W12 x H8mm, 0° | 
| 08809228124145 | PEEK Cage, L32 x W12 x H7mm, 0° | 
| 08809228124138 | PEEK Cage, L28 x W10 x H15mm, 0° | 
| 08809228124121 | PEEK Cage, L28 x W10 x H14mm, 0° | 
| 08809228124114 | PEEK Cage, L28 x W10 x H13mm, 0° | 
| 08809228124107 | PEEK Cage, L28 x W10 x H12mm, 0° | 
| 08809228124091 | PEEK Cage, L28 x W10 x H11mm, 0° | 
| 08809228124084 | PEEK Cage, L28 x W10 x H10mm, 0° | 
| 08809228124077 | PEEK Cage, L28 x W10 x H9mm, 0° | 
| 08809228124060 | PEEK Cage, L28 x W10 x H8mm, 0° | 
| 08809228124053 | PEEK Cage, L28 x W10 x H7mm, 0° | 
| 08809763509896 | Root Retractor(Small) | 
| 08809763509889 | Root Retractor(Large) | 
| 08809763509858 | Ball Curette(Right) | 
| 08809763509841 | Ball Curette(Left) | 
| 08809763509483 | Trial(D4W12L32H14) | 
| 08809763509476 | Trial(D4W12L32H13) | 
| 08809763509469 | Trial(D4W12L32H12) | 
| 08809763509452 | Trial(D4W12L32H11) | 
| 08809763509445 | Trial(D4W12L32H10) | 
| 08809763509438 | Trial(D4W12L32H9) | 
| 08809763509421 | Trial(D4W12L32H8) | 
| 08809763509414 | Trial(D4W12L32H7) | 
| 08809763509308 | Trial(D4W10L28H14) | 
| 08809763509292 | Trial(D4W10L28H13) |