| Primary Device ID | 00198506083532 |
| NIH Device Record Key | 84197fe7-e26f-4e05-bd99-ce5256a4c899 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELMED 00198506083532 |
| Version Model Number | 20-41174 |
| Catalog Number | 20-41174 |
| Company DUNS | 049290364 |
| Company Name | ELMED INCORPORATED |
| 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 | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com | |
| Phone | 224-353-6446 |
| medical@elmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00198506083532 [Primary] |
| HCF | Instrument, Ligature Passing And Knot Tying |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
[00198506083532]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-17 |
| Device Publish Date | 2025-06-09 |
| 00198506008481 - ELMED INCORPORATED | 2025-07-21 NEEDLE CURVED POINTED, ROSEN, 15.5CM |
| 00198506040177 - ELMED INCORPORATED | 2025-07-21 5 MM DIA., 32 CM, HASSON GRASPER 3 PRONG BULLDOG, AGGRESSIVE JAWS |
| 00198506083952 - ELMED INCORPORATED | 2025-07-21 MOTOR GEAR WHEEL - LARGE |
| 00198506083969 - ELMED INCORPORATED | 2025-07-21 Metz. Scissors Single Action, Cystoscopy Flexible, 5FR (1.6mm) Dia., 40cm Length |
| 00198506083976 - ELMED INCORPORATED | 2025-07-21 19CM (7 1/2") ELMED BIPOLAR CURVED CLAMP/SCISSOR COMBINATION, HEAVY DUTY SYNTHETIC BLUE INSULATION |
| 00198506083983 - ELMED INCORPORATED | 2025-07-21 NAIL NIPPER, CONCAVE, 4 3/4”, DOUBLE SPRING HANDLE |
| 00198506083990 - ELMED INCORPORATED | 2025-07-21 GLENOSPHERE COMPONENT RETRACTOR; 10.25 OAL, 2.4CM BLADE WIDTH |
| 00198506084003 - ELMED INCORPORATED | 2025-07-21 5FR, 40CM, GRASPING FORCEPS, 1X1 TEETH, DOUBLE ACTION, SEMI-RIGID |