| Primary Device ID | 00853508002515 |
| NIH Device Record Key | 659de541-6358-421b-87aa-983367c2ad3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BE-ST Ligament Tensioner |
| Version Model Number | 110040370 |
| Catalog Number | 110040370 |
| Company DUNS | 958212029 |
| Company Name | Lacey Manufacturing Company, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com | |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com | |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com | |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com | |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com | |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com | |
| Phone | 203-336-7453 |
| jim.rogers@ametek.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853508002515 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00853508002515]
Radiation Sterilization
[00853508002515]
Radiation Sterilization
[00853508002515]
Radiation Sterilization
[00853508002515]
Radiation Sterilization
[00853508002515]
Radiation Sterilization
[00853508002515]
Radiation Sterilization
[00853508002515]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-17 |
| Device Publish Date | 2026-03-09 |
| 00853508002515 - BE-ST Ligament Tensioner | 2026-03-17The BE-ST Ligament Tensioner is a non-powered hand held device used in orthopedic surgery. |
| 00853508002515 - BE-ST Ligament Tensioner | 2026-03-17 The BE-ST Ligament Tensioner is a non-powered hand held device used in orthopedic surgery. |
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| 00853508002171 - BEST | 2023-06-23 Sheathed Bayonet Surgical Knife |
| 00853508002188 - BEST | 2023-06-23 Sheathed Bayonet Surgical Knife |