Primary Device ID | 00821925002487 |
NIH Device Record Key | ba8da613-954b-4c66-9226-5f6cf93d7edf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | USA Elite System |
Version Model Number | GYA-742 |
Company DUNS | 007198742 |
Company Name | Gyrus ACMI, LLC |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821925002487 [Primary] |
HIH | Hysteroscope (And Accessories) |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
[00821925002487]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-05 |
Device Publish Date | 2024-11-27 |
00821925002104 | USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 27.6 Fr, (9.2 mm) Color Co |
00821925002487 | Semi-Rigid Gynecologic Alligator Forceps 7 Fr (2.3 mm), 42 CM |