Simplex 6191-1-001

GUDID 37613327128445

Full Dose Bone Cement, 10 pack catalog number is 6191-1-010

Howmedica Osteonics Corp.

Orthopaedic cement, non-medicated
Primary Device ID37613327128445
NIH Device Record Key508849b3-27d6-4351-9e71-5cc284f6b561
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplex
Version Model Number6191-1-001
Catalog Number6191-1-001
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight40 Gram
Total Volume20 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 6 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327128444 [Primary]
GS137613327128445 [Package]
Contains: 07613327128444
Package: pack [10 Units]
In Commercial Distribution
GS157613327128449 [Package]
Package: case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LODBONE CEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [Simplex]

37613327128452SpeedSet Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6192-1-010
37613327128445Full Dose Bone Cement, 10 pack catalog number is 6191-1-010
57613327128432Half Dose Bone Cement, 10 pack catalog number is 6188-1-010
37613327128421Tobra Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6197-9-010

Trademark Results [Simplex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLEX
SIMPLEX
98694375 not registered Live/Pending
Rockefeller Holdings LLC
2024-08-12
SIMPLEX
SIMPLEX
98405525 not registered Live/Pending
Box House Inc.
2024-02-14
SIMPLEX
SIMPLEX
98306377 not registered Live/Pending
Enerpac Tool Group Corp.
2023-12-08
SIMPLEX
SIMPLEX
98306369 not registered Live/Pending
Enerpac Tool Group Corp.
2023-12-08
SIMPLEX
SIMPLEX
97846931 not registered Live/Pending
Simplex Manufacturing Co.
2023-03-20
SIMPLEX
SIMPLEX
97705048 not registered Live/Pending
Erwin Halder KG
2022-12-06
SIMPLEX
SIMPLEX
97439099 not registered Live/Pending
Assure Tech (Hangzhou) Co., Ltd.
2022-06-01
SIMPLEX
SIMPLEX
97272475 not registered Live/Pending
LSP Products Group, Inc.
2022-02-17
SIMPLEX
SIMPLEX
90141180 not registered Live/Pending
Simplex Health Corp
2020-08-27
SIMPLEX
SIMPLEX
88510138 not registered Live/Pending
SPARK ENGINEERING PVT. LTD.
2019-07-11
SIMPLEX
SIMPLEX
88495915 not registered Live/Pending
TRICARE
2019-07-01
SIMPLEX
SIMPLEX
88458742 not registered Live/Pending
SIMPLEX PROFESSIONAL SERVICES, INC.
2019-06-04

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