| 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 |
| 00198506006968 - ELMED INCORPORATED | 2025-07-01 PILLSBURY-JESBERG ESOPHAGOSCOPE, 10 X 14 X 29 (292MM OVERALL LENGTH) |
| 00198506026157 - ELMED INCORPORATED | 2025-07-01 5MM DIA., 32CM KLEPPINGER, SCISSORS TYPE, BIPOLAR FORCEPS WITHOUT TONG |
| 00198506043154 - ELMED INCORPORATED | 2025-07-01 5MM DIA., 24 CM, WAVE FUNDUS GRASPER, LONG BEVELED EDGE JAWS, FOR LARGE GRASP ON TISSUE, SINGLE-ACTION, INSULATED SHAFT, SLIDE-L |
| 00198506056574 - ELMED INCORPORATED | 2025-07-01 1" (25MM), 6" (150MM) ELMED FIBER OPTIC BRITETRAC RETRACTOR, BLUE SILICONE HANDLE, ANGLED DOWN TIP |
| 00198506083655 - ELMED INCORPORATED | 2025-07-01 FRASIER SUCTION 15FR., EBONIZED |
| 00198506083662 - ELMED INCORPORATED | 2025-07-01 VASCULAR FORCEPS; TISSUE, DEBAKEY, 19CM, 1.65MM X 12MM JAWS |
| 00198506083679 - ELMED INCORPORATED | 2025-07-01 STERNUM RETRACTOR; MORSE, ADULT, 8" W X 7-1/2" ARM X 1-1/8" BLADE |
| 00198506083686 - ELMED INCORPORATED | 2025-07-01 BULLDOG CLAMP CURVED 60MM |