Insertion Package

GUDID 00878953000558

Tubing Passer

AMERICAN MEDICAL SYSTEMS, INC.

Wire/ligature passer, reusable

Primary Device ID	00878953000558
NIH Device Record Key	26a1c585-a80c-4bb6-9538-e6fe23a94322
Commercial Distribution Status	In Commercial Distribution
Brand Name	Insertion Package
Version Model Number	72100005
Company DUNS	125111448
Company Name	AMERICAN MEDICAL SYSTEMS, 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	00878953000534 [Direct Marking]
GS1	00878953000558 [Primary]

FDA Product Code

JCW	Prosthesis, Penis, Inflatable
QGA	Penile implant surgical accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

[00878953000558]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-02-13
Device Publish Date	2014-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

00878953002774 - AMS 700 CXR RTE Kit	2019-10-11 Rear Tip Extender Kit, 2 Each 4.0 cm, 5.0 cm, 6.0 cm
00878953004044 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004051 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004068 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004075 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004082 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004099 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
00878953004105 - Rear Tip Extender	2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis

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