| Primary Device ID | 00198506059674 |
| NIH Device Record Key | c1ebc2f4-7173-49e7-bc81-ab6be9c46c81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELMED INCORPORATED |
| Version Model Number | 42-2115 |
| Catalog Number | 42-2115 |
| 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 | |
| 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 | 00198506059674 [Primary] |
| LRC | Instrument, Ent Manual Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
[00198506059674]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-22 |
| Device Publish Date | 2024-07-12 |
| 00198506059933 | 5MM, 45CM, HUNTER DEBAKEY, FENESTRATED, 30MM, ROTATABLE, ONE PIECE W/ FLUSHPORT |
| 00198506059926 | Debakey Heparin Needle Large, Malleable, 4mm Distal Tip with 4 lateral holes and one distal hole |
| 00198506059919 | FIBER OPTIC RETRACTOR; TEBBET STYLE, 3CM X 9CM, W/ SUCTION, RIGHT ANGLE TAPERED TIP W/ TEETH |
| 00198506059902 | 5 Fr. (1.6 mm) 40cm, Alligator Grasping Forceps Semi-Rigid |
| 00198506059896 | 10 MM DIA., 37.5 CM, ANVIL GRASPER WITH SPECIAL SHAPED JAWS TO GRASP AND HOLD THE ANVIL OF A CIR |
| 00198506059872 | NATHANSON PEDI LIVER RETRACTOR 3.0MM, SMALL -->"REF: 69735-3" |
| 00198506059681 | SCISSORS, CURVED UP 45 DEG |
| 00198506059674 | SCISSORS, CURVED UP 150 |
| 00198506059667 | SCISSORS, STRAIGHT |
| 00198506059650 | ALLIGATOR FORCEPS, SERRATED, STRAIGHT |
| 00198506059971 | T/C NEEDLE HOLDER; VASCULAR, 6", SLENDER |
| 00198506059964 | T/C NEEDLE HOLDER; VASCULAR, 6", DELICATE/SLENDER |
| 00198506059957 | 3.4MM DIAMETER GRASPING FORCEP RING HANDLE W/ RATCHET |
| 00198506060052 | HEMOSTATIC FORCEPS, ROCHESTER-OCHSNER, 1X2 TEETH, CURVED, 18CM |
| 00198506060045 | UNIVERSAL SCOPE HOLDER W/ POSITIVE SCOPE ARTICULATION AND CHEST BAR, DIRECT MOUNTING FOR SCOPES |
| 00198506060021 | Reul Coronary Tissue Forcep, 8", Carbite Tip, Delicate |
| 00198506060014 | UNIVERSAL SPRING FOR KERRISON RONGEUR CLEAR FLUSH HANDLE |
| 00198506060007 | Wolf Suction Irrigation Handle, Refurbished |