| Primary Device ID | J003E0515341012001 | 
| NIH Device Record Key | e3da7edb-c95d-481b-a3fe-58e54d82b8fc | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | CF | 
| Version Model Number | E051534101200 | 
| Catalog Number | E051534101200 | 
| Company DUNS | 480538495 | 
| Company Name | MAILLEFER INSTRUMENTS HOLDING Sàrl | 
| 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 | false | 
| OTC Over-The-Counter | false | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Special Storage Condition, Specify | Between 0 and 0 *N/A | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | J003E0515341012001 [Primary] | 
| EJL | BUR, DENTAL | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
[J003E0515341012001]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-11-28 | 
| Device Publish Date | 2022-11-20 |