Primary Device ID | 00841494104818 |
NIH Device Record Key | a5930dc0-e6d2-4be7-b415-a08e2cc4db8c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SUCTION HANDLE FOR CORNEAL SHIELDS |
Version Model Number | H78A |
Catalog Number | H78A |
Company DUNS | 079095245 |
Company Name | Ellman International |
Device Count | 2 |
DM Exempt | true |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841494104818 [Primary] |
GS1 | 00841494106546 [Unit of Use] |
HOY | Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-05-23 |
Device Publish Date | 2016-09-21 |
00841494102371 - CORNEAL SHIELD | 2019-05-23 CORNEAL SHIELD L(BLUE), 4 SHIELD, 1 HDLE |
00841494102388 - CORNEAL SHIELD | 2019-05-23 CORNEAL SHIELD M(GREEN),4 SHIELD,1 HDLE |
00841494102395 - CORNEAL SHIELD | 2019-05-23 CORNEAL SHIELD S(RED),4 SHIELDS,1 HANDLE |
00841494102401 - CORNEAL SHIELDS | 2019-05-23 CORNEAL SHIELDS ASSORTED PACKAGE(S, M, L) |
00841494104801 - SUCTION HANDLE | 2019-05-23 SUCTION HANDLE(25PCS)FOR CORNEAL SHIELDS |
00841494104818 - SUCTION HANDLE FOR CORNEAL SHIELDS | 2019-05-23SUCTION HANDLE(2PCS) FOR CORNEAL SHIELDS |
00841494104818 - SUCTION HANDLE FOR CORNEAL SHIELDS | 2019-05-23 SUCTION HANDLE(2PCS) FOR CORNEAL SHIELDS |
00841494101015 - 1/8" PIN ELECTRODE | 2019-02-07 1/8" PIN ELECTRODE - 25 PCS STERILE |
00841494101305 - Needle Electrode | 2019-02-07 3/4" STRAIGHT NEEDLE STERILE, SINGLE-USE |