DynaLube, Lubricating Jelly Sterile, 5 g

GUDID 00810180842617

Dynarex Corporation

General-body orifice lubricant
Primary Device ID00810180842617
NIH Device Record Keycf282e02-21c9-456f-9691-604bdca9e41e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaLube, Lubricating Jelly Sterile, 5 g
Version Model Number1251
Company DUNS008124539
Company NameDynarex Corporation
Device Count72
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784125121 [Primary]
GS100616784125138 [Package]
Contains: 00616784125121
Package: Case [12 Units]
In Commercial Distribution
GS100810180842617 [Unit of Use]

FDA Product Code

KMJLubricant, Patient

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-02-04
Device Publish Date2022-05-23

Devices Manufactured by Dynarex Corporation

00810180843249 - Disposable Coveralls2026-02-24 Disposable Coveralls, Universal Size, White
00810180843126 - Shoe Cover2026-02-23 Shoe Cover- Universal Size, Non-Conductive, 150 Pairs
00810180843133 - Shoe Cover2026-02-23 Shoe Cover- Universal Size, Non-Conductive, Non-Skid, 150 Pairs
00810180843140 - Shoe Cover2026-02-23 Shoe Cover, Non-Conductive and Non-Skid, XL
00810180843164 - Disposable BP Cuff Barrier Sleeves2026-02-23 Disposable BP Cuff Barrier Sleeves, Non-Woven, White, Universal
00810180842716 - Electrode Skin Prep Pads2026-02-17
00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g 2026-02-04
00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g 2026-02-04
00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet2026-02-03

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.