Primary Device ID | 08809763504310 |
NIH Device Record Key | 2851919d-1d03-4d6f-8dbb-d1e76178fdb3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INNESIS PEEK CAGE |
Version Model Number | 52780-08 |
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 | 08809763504310 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
Moist Heat or Steam Sterilization
[08809763504310]
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 |
08809228120888 | PEEK Cage, L23 x W11 x H14mm, 8° |
08809228120871 | PEEK Cage, L23 x W11 x H13mm, 8° |
08809228120864 | PEEK Cage, L23 x W11 x H12mm, 8° |
08809228120857 | PEEK Cage, L23 x W11 x H11mm, 8° |
08809228120840 | PEEK Cage, L23 x W11 x H10mmH, 8° |
08809228120833 | PEEK Cage, L23 x W11 x H14mm, 4° |
08809228120826 | PEEK Cage, L23 x W11 x H13mm, 4° |
08809228120819 | PEEK Cage, L23 x W11 x H12mm, 4° |
08809228120802 | PEEK Cage, L23 x W11 x H11mm, 4° |
08809228120796 | PEEK Cage, L23 x W11 x H10mm, 4° |
08809228120789 | PEEK Cage, L23 x W11 x H9mm, 4° |
08809228120772 | PEEK Cage, L23 x W11 x H14mm, 0° |
08809228120765 | PEEK Cage, L23 x W11 x H13mm, 0° |
08809228120758 | PEEK Cage, L23 x W11 x H12mm, 0° |
08809228120741 | PEEK Cage, L23 x W11 x H11mm, 0° |
08809228120734 | PEEK Cage, L23 x W11 x H10mm, 0° |
08809228120727 | PEEK Cage, L23 x W11 x H9mm, 0° |
08809228120710 | PEEK Cage, L23 x W11 x H8mm, 0° |
08809763509872 | Dura Retractor |
08809763509865 | Root Retractor |
08809763506680 | Shaver 13.0mm |
08809763506673 | Shaver 12.0mm |
08809763506666 | Shaver 11.0mm |
08809763506659 | Shaver 10.0mm |
08809763506642 | Shaver 9.0mm |
08809763506635 | Shaver 8.0mm |
08809763506628 | Shaver 7.0mm |
08809763505812 | SQ-Adapter Handle |
08809763504389 | Cage Impactor |
08809763504365 | Distractor 13.0mm |
08809763504358 | Distractor 12.0mm |
08809763504341 | Distractor 11.0mm |
08809763504334 | Distractor 10.0mm |
08809763504327 | Distractor 9.0mm |
08809763504310 | Distractor 8.0mm |
08809763504303 | Distractor 7.0mm |
08809763504297 | Graft Impactor |
08809763504280 | Final Impactor |
08809763504204 | Cage Support |
08809763506871 | Shaver 14.0mm |
08809763506864 | Shaver 13.0mm |
08809763506857 | Shaver 12.0mm |
08809763506840 | Shaver 11.0mm |
08809763506833 | Shaver 10.0mm |
08809763506826 | Shaver 9.0mm |
08809763506819 | Shaver 8.0mm |
08809763506802 | Shaver 7.0mm |
08809763506796 | Shaver 6.0mm |
08809763506789 | Shaver 14.0mm |
08809763506772 | Shaver 13.0mm |