Amielle SM2100

GUDID 00384702100030

Vaginal dilator

Primary Device ID	00384702100030
NIH Device Record Key	6f1c6a04-a108-48a0-af36-11e6b4d70b66
Commercial Distribution Status	In Commercial Distribution
Brand Name	Amielle
Version Model Number	SM2100
Catalog Number	SM2100
Company DUNS	803401454
Company Name	OWEN MUMFORD USA INCORPORATED
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	true
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

Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00384702100016 [Primary]
GS1	00384702100030 [Package] Contains: 00384702100016 Package: Case [25 Units] In Commercial Distribution

KXP	Stent, Vaginal

Steralize Prior To Use	false
Device Is Sterile	false

00761059354024 - Unifine Pentips	2024-02-13 Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G
00761059352921 - Unifine Pentips	2024-01-30 Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G
00384707001035 - Unistik VacuFlip	2023-10-16 Unistik VacFlip, 20G Safety Needle 1"
00384707102039 - Unistik VacuFlip	2023-10-16 Unistik VacuFlip, 21G safety needle 1" with holder
00384707117033 - Unistik ShieldLock	2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer 8" tubing
00384707122037 - Unistik ShieldLock	2023-10-16 Unistik ShieldLock 21G Safety Winged Set w/ Luer and holder 12" tubing
00384707312032 - Unistik ShieldLock	2023-10-16 Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing
00384707317037 - Unistik ShieldLock	2023-10-16 Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing

Mark Image Registration \| Serial	Company Trademark Application Date
AMIELLE 86102398 5061716 Live/Registered	Owen Mumford Limited 2013-10-25