DynaLube, Sterile, 2.7 g Packet

GUDID 00616784125015

DYNAREX CORPORATION

General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant
Primary Device ID00616784125015
NIH Device Record Keyeef1cb87-9bfb-42ba-b1f5-5b662ed319ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaLube, Sterile, 2.7 g Packet
Version Model Number1250
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count144
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
GS100616784125015 [Unit of Use]
GS100616784125022 [Primary]
GS100616784125039 [Package]
Contains: 00616784125022
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

KMJLubricant, Patient

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-31
Device Publish Date2022-05-23

Devices Manufactured by DYNAREX CORPORATION

00840117334151 - Dyna-Safety Nitrile Exam Gloves,Powder-Free,Blue,X-Large2024-03-26
00840117335868 - DynaSafety Sterile Gauze Pad, All Gauze 2024-03-26 3" x 3", 12-ply
08401173314574 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25
08401173314710 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25 1" x 3"
08401173314956 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25 1" x 3"
00840117331501 - DynaSafety Sheer Plastic Adhesive Bandages Sterile with Non-Stick Pad2024-03-25 1" x 3"
00840117334274 - Resp-O2 CPAP Tubing 4' ( 1.2m )2024-03-25
00840117334298 - Resp-O2 CPAP Tubing 6' ( 1.8 m )2024-03-25

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