| Primary Device ID | 08806373878022 |
| NIH Device Record Key | 5fe10421-a4e2-47f0-91f5-697710bc6255 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOSPA&LOSPA IS Surgical Instruments |
| Version Model Number | SI.ZH1.0002 |
| Company DUNS | 688739895 |
| Company Name | Corentec 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 | true |
| 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 |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806373878022 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
[08806373878022]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-02 |
| Device Publish Date | 2025-11-24 |
| 08806373886850 - BENCOX Surgical Instruments | 2025-12-18 Rasp Handle |
| 08806373888212 - BENCOX Surgical Instruments | 2025-12-18 BENCOX Cup 42-54mm Template (Delta) 105% |
| 08806373888229 - BENCOX Surgical Instruments | 2025-12-18 BENCOX Cup 56-68mm Template (Delta) 105% |
| 08806373888250 - BENCOX Surgical Instruments | 2025-12-18 BENCOX Cup 42-54mm Template (Delta) 115% |
| 08806373888267 - BENCOX Surgical Instruments | 2025-12-18 BENCOX Cup 56-68mm Template (Delta) 115% |
| 08806373888298 - BENCOX Surgical Instruments | 2025-12-18 BENCOX Cup 42-54mm Template (Delta) 120% |
| 08806373888304 - BENCOX Surgical Instruments | 2025-12-18 BENCOX Cup 56-68mm Template (Delta) 120% |
| 08806373892004 - BENCOX Surgical Instruments | 2025-12-18 Canal Probe |