USA Elite System

GUDID 00821925002487

Semi-Rigid Gynecologic Alligator Forceps 7 Fr (2.3 mm), 42 CM

Gyrus ACMI, LLC

Rigid endoscopic tissue manipulation forceps, reusable
Primary Device ID00821925002487
NIH Device Record Keyba8da613-954b-4c66-9226-5f6cf93d7edf
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSA Elite System
Version Model NumberGYA-742
Company DUNS007198742
Company NameGyrus ACMI, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925002487 [Primary]

FDA Product Code

HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-05
Device Publish Date2024-11-27

On-Brand Devices [USA Elite System]

00821925002104USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 27.6 Fr, (9.2 mm) Color Co
00821925002487Semi-Rigid Gynecologic Alligator Forceps 7 Fr (2.3 mm), 42 CM

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