Rapport Rings - Size 6 SM2206

GUDID 00384702206039

Rapport constriction rings - Size 6

OWEN MUMFORD USA INCORPORATED

Penile vacuum device
Primary Device ID00384702206039
NIH Device Record Key0a53ee49-b034-4bbd-9246-7a1543c6e35c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapport Rings - Size 6
Version Model NumberSM2206
Catalog NumberSM2206
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter
Lumen/Inner Diameter18.5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384702206015 [Primary]
GS100384702206039 [Package]
Contains: 00384702206015
Package: Case [1 Units]
In Commercial Distribution

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

Devices Manufactured by OWEN MUMFORD USA INCORPORATED

00761059354024 - Unifine Pentips2024-02-13 Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G
00761059352921 - Unifine Pentips2024-01-30 Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G
00384707001035 - Unistik VacuFlip2023-10-16 Unistik VacFlip, 20G Safety Needle 1"
00384707102039 - Unistik VacuFlip2023-10-16 Unistik VacuFlip, 21G safety needle 1" with holder
00384707117033 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer 8" tubing
00384707122037 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing
00384707312032 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing
00384707317037 - Unistik ShieldLock2023-10-16 Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.