Primary Device ID | 00821925027565 |
NIH Device Record Key | 8b4550bd-ea81-4114-bf07-ba28aa7a9a80 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PKS BiLL |
Version Model Number | BL0533 |
Company DUNS | 007198742 |
Company Name | Gyrus Acmi, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 | 00821925027565 [Package] Contains: 00821925039537 Package: [5 Units] In Commercial Distribution |
GS1 | 00821925039537 [Primary] |
HIN | COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-04-23 |
Device Publish Date | 2017-05-11 |
00810008180983 - nCare | 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG |
00810008180990 - nCare | 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG |
00810008180501 - nCare | 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg |
00810008180921 - nCare | 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg |
00810008180952 - nCare | 2023-09-25 nCare, SNGL,DRCT SDI,DICOM |
00810008180969 - nCare | 2023-09-25 nCare, SNGL, ELA, DICOM |
00810008180976 - nCare | 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG |
00821925036406 - USA Elite | 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm) |