| Primary Device ID | 05415067009746 |
| NIH Device Record Key | 9f00748a-0296-4834-87fb-0b6d0b4ae994 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM™ |
| Version Model Number | Flexible Holder Handle |
| Catalog Number | MHV-HHL3 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| 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 | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Length | 10.1 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Special Storage Condition, Specify | Between 0 and 0 *May be stored indefinitely. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067009746 [Primary] |
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
[05415067009746]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-02-01 |