velvet XP 200 TTNF204

GUDID 00841277108927

velvet XP 200 Nitrile Exam Glove PF, size L

SEMPERMED USA, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00841277108927
NIH Device Record Keyf7b4ac47-bccb-41bd-b69a-0292f6bfe808
Commercial Distribution Discontinuation2024-11-15
Commercial Distribution StatusNot in Commercial Distribution
Brand Namevelvet XP 200
Version Model NumberTTNF204
Catalog NumberTTNF204
Company DUNS004072158
Company NameSEMPERMED USA, INC.
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841277108873 [Primary]
GS100841277108927 [Unit of Use]

FDA Product Code

OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-25
Device Publish Date2024-11-15

On-Brand Devices [velvet XP 200]

00841277108934velvet XP 200 Nitrile Exam Glove PF, size XL
00841277108927velvet XP 200 Nitrile Exam Glove PF, size L
00841277108910velvet XP 200 Nitrile Exam Glove PF, size M
00841277108903velvet XP 200 Nitrile Exam Glove PF, size S
00841277108897velvet XP 200 Nitrile Exam Glove PF, size XS

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