EXT CORD NEEDLE ELECT. NS

GUDID 00821925009608

Gyrus Acmi, Inc.

Electrosurgical cable adaptor

Primary Device ID	00821925009608
NIH Device Record Key	e164ab8d-d429-42ee-bf7b-54e13665d5f2
Commercial Distribution Status	In Commercial Distribution
Brand Name	EXT CORD NEEDLE ELECT. NS
Version Model Number	3481
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
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	false
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 Identifiers

Device Issuing Agency	Device ID
GS1	00821925009608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K003569

FDA Product Code

KNS	Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925009608]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

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[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

[00821925009608]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-10-12
Device Publish Date	2018-09-11

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