Primary Device ID | 16971381251637 |
NIH Device Record Key | 0b897bc6-6326-4fb8-bfb8-af1582839747 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Single-use Guidewire |
Version Model Number | GW-3515 |
Company DUNS | 544519831 |
Company Name | SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
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 | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06971381251630 [Primary] |
GS1 | 16971381251637 [Package] Contains: 06971381251630 Package: [5 Units] In Commercial Distribution |
GS1 | 26971381251634 [Package] Package: [180 Units] In Commercial Distribution |
OCY | Endoscopic Guidewire, Gastroenterology-Urology |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-01 |
Device Publish Date | 2023-05-24 |
06971381251357 - Insufflator | 2024-03-07 The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to provide visual field and operat |
06971381251364 - Insufflator | 2024-03-07 The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to provide visual field and operat |
16971381253143 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253150 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253167 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253174 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253181 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253198 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |