SCOPE, CABOT LAPAROCATOR

GUDID 00821925000186

Gyrus Acmi, Inc.

Rigid endoscope telescope

Primary Device ID	00821925000186
NIH Device Record Key	41dcda1c-e459-4d80-b219-27d890bff8f3
Commercial Distribution Status	In Commercial Distribution
Brand Name	SCOPE, CABOT LAPAROCATOR
Version Model Number	002399-501
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	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 Identifiers

Device Issuing Agency	Device ID
GS1	00821925000186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P870076

FDA Product Code

KNH	Laparoscopic contraceptive tubal occlusion device

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

[00821925000186]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-05-08

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00821925002074 - USA Elite System	2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002098 - USA Elite System	2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
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