M3 Gold

GUDID 00821925007338

M3 Gold Autoclavable Operative Telescope 12 Degree, Color Coded Green

Gyrus Acmi, Inc.

Rigid endoscope telescope

Primary Device ID	00821925007338
NIH Device Record Key	eed333a4-f594-401e-87ad-f5d18cdc3969
Commercial Distribution Status	In Commercial Distribution
Brand Name	M3 Gold
Version Model Number	REXM3-12A
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	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925007338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

HIH	Hysteroscope (And Accessories)

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

[00821925007338]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-07-31
Device Publish Date	2024-07-23

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