| 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 |
| 00198506088308 - ELMED INCORPORATED | 2026-02-09 LASER BLACK DEMARRES LID RETRACTORS, 14MM, 5” OVERALL LENGTH |
| 00198506088315 - ELMED INCORPORATED | 2026-02-09 10MM DIA., 30CM, CURVED MASHER FORCEPS THIN TEAR DROP,ELMED ERGONOMIC STRAIGHT RING AXIAL HANDLE,( RECOMMEND LOCKING HANDLE),W/F |
| 00198506088322 - ELMED INCORPORATED | 2026-02-09 WELDMENT, TUBE AND HOUSING (QTY 2 REQ.) |
| 00198506088339 - ELMED INCORPORATED | 2026-02-09 INSULATED RICHARDSON RETRACTOR, 1-1/4" X 1-1/8" - 9-1/4" OVERALL LENGTH |
| 00198506088346 - ELMED INCORPORATED | 2026-02-09 OPTICAL RETRACTOR FOR 11" 30 DEGREE SCOPE |
| 00198506088193 - ELMED INCORPORATED | 2026-02-04 "10MM, 33CM, SPOON FORCEPS, SHORT 10MM JAW LENGTH STAINLESS STEEL, NON-ROTATING, B: NON-INSULATED STAINLESS STEEL W/ SPRING ASSI |
| 00198506088209 - ELMED INCORPORATED | 2026-02-04 10MM DIA., 45CM, BABCOCK GRASPER, SLIDE LOCK, ROTATABLE ONE - PIECE (B) |
| 00198506088223 - ELMED INCORPORATED | 2026-02-04 Micro Needle Holders, Titanium Straight, Round Handle, Diamond Coated Jaws, With Lock, 7 - 0 Suture Size, 7 1/4" (18.5cm) |