Primary Device ID | 08717213057760 |
NIH Device Record Key | 10ebac8b-1232-4d56-bb5e-26142c22607c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Esteya |
Version Model Number | 187001SE |
Company DUNS | 415269930 |
Company Name | Nucletron B.V. |
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 | false |
Lot Batch | false |
Serial Number | true |
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 | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com | |
Phone | +1(770)300-9725 |
info.america@elekta.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08717213057760 [Primary] |
JAD | System, Therapeutic, X-Ray |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-08-24 |
Device Publish Date | 2022-08-16 |
08717213054363 - Luneray | 2022-11-23 Catheter 6F 50cm, needle 37mm R30mm |
08717213054370 - Luneray | 2022-11-23 Catheter 6F 50cm, needle 47mm R45mm |
08717213054387 - Luneray | 2022-11-23 Catheter 6F 50cm, needle 57mm R60mm |
08717213054394 - Luneray | 2022-11-15 Catheter 6F 50cm, needle 67mm R75mm |
08717213057760 - Esteya | 2022-08-24Esteya |
08717213057760 - Esteya | 2022-08-24 Esteya |
08717213056947 - NA | 2022-07-08 INSERTION TOOL |
08717213008991 - X-ray Catheters | 2022-06-10 X-Ray Catheter Set Standard USA GYN SS |
08717213009387 - X-ray Catheters | 2022-06-10 GYN X-Ray Catheter Set (channel 1-3) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ESTEYA 79116060 4366437 Live/Registered |
Nucletron Operations B.V. 2012-05-21 |