Surgilube 281020537

GUDID 20851809002450

Sterile Surgical Lubricant, Tube

HR PHARMACEUTICALS INC.

General-body orifice lubricant, sterile
Primary Device ID20851809002450
NIH Device Record Key4038d600-f3f8-4aa5-853a-7c55c3bdf17e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgilube
Version Model Number281020537
Catalog Number281020537
Company DUNS828918164
Company NameHR PHARMACEUTICALS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com
Phone+1(717)252-1110
Emailchris.wiesman@hrpharma.com

Device Dimensions

Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram
Weight120.49 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
NDC/NHRIC00281020537 [Secondary]
GS100851809002456 [Primary]
GS110851809002453 [Package]
Contains: 00851809002456
Package: Box [12 Units]
In Commercial Distribution
GS120851809002450 [Package]
Contains: 10851809002453
Package: Case [6 Units]
In Commercial Distribution

FDA Product Code

KMJLubricant, patient

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


[20851809002450]

Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-27
Device Publish Date2018-08-27

On-Brand Devices [Surgilube]

30851809002471Sterile Surgical Lubricant, Packet
30851809002464Sterile Surgical Lubricant, Metal Tube
20851809002450Sterile Surgical Lubricant, Tube
10851809002446Sterile Surgical Lubricant, Metal Tube
20851809002436Sterile Surgical Lubricant, Tube
20851809002429Sterile Surgical Lubricant, Metal Tube
20851809002412Sterile Surgical Lubricant, Packet
20851809002405Sterile Surgical Lubricant, Packet

Trademark Results [Surgilube]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGILUBE
SURGILUBE
88523981 not registered Live/Pending
HR Pharmaceuticals, Inc.
2019-07-19
SURGILUBE
SURGILUBE
88523968 not registered Live/Pending
HR Pharmaceuticals, Inc.
2019-07-19
SURGILUBE
SURGILUBE
88523945 not registered Live/Pending
HR Pharmaceuticals, Inc.
2019-07-19
SURGILUBE
SURGILUBE
71332087 0302457 Live/Registered
DAY CHEMICAL COMPANY
1932-11-12

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.