Primary Device ID | 00878953005409 |
NIH Device Record Key | 0e87524b-6bd5-4309-9b6c-e92f7e6a1c3f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spectra RTE Kit |
Version Model Number | 720171-01 |
Company DUNS | 125111448 |
Company Name | AMERICAN MEDICAL SYSTEMS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Outer Diameter | 9.5 Millimeter |
Outer Diameter | 9.5 Millimeter |
Outer Diameter | 9.5 Millimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Length | 6 Centimeter |
Length | 5 Centimeter |
Length | 4 Centimeter |
Outer Diameter | 9.5 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00878953005409 [Primary] |
FAE | Prosthesis, Penile |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-02-13 |
Device Publish Date | 2016-08-12 |
00878953005409 | Rear Tip Extender Kit 2 Each: 4.0 cm, 5.0 cm, 6.0 cm |
00878953005393 | Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm |