Sterile Nitrile Surgical Gloves

GUDID 00616784653914

Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size 9

DYNAREX CORPORATION

Nitrile surgical glove, non-powdered
Primary Device ID00616784653914
NIH Device Record Keyd7bb732c-fa23-4ce3-8068-f950d5293be6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Nitrile Surgical Gloves
Version Model Number6539
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784653914 [Primary]
GS100616784653921 [Package]
Package: Box [50 Units]
In Commercial Distribution
GS100616784653938 [Package]
Contains: 00616784653921
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGOSurgeon'S Gloves

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-02
Device Publish Date2022-04-22

On-Brand Devices [Sterile Nitrile Surgical Gloves]

00616784653914Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
00616784653815Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
00616784653716Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
00616784653617Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
00616784653518Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
00616784653419Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
00616784653310Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size

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