| Primary Device ID | G25012195240 |
| NIH Device Record Key | 0d2218d6-59c5-4e26-ac45-0538b5b75f75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lambotte Osteotomes Curved 13mm |
| Version Model Number | 12-195-24 |
| Catalog Number | 12-195-24 |
| Company DUNS | 645681649 |
| Company Name | N S SURGICAL COMPANY |
| 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 | 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 | true |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Length | 24.5 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G25012195240 [Primary] |
| HWM | Osteotome |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
[G25012195240]
Ethylene Oxide;Moist Heat or Steam Sterilization;Ultraviolet Light
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-02 |
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| G25012195240 - Lambotte Osteotomes Curved 13mm | 2023-09-11A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device. |
| G25012195240 - Lambotte Osteotomes Curved 13mm | 2023-09-11 A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic proced |