Foundation 27-500-100

GUDID 20386040015247

Collagen-Based Bone Filling Augmentation Material

Gc America Inc.

Dental bone matrix implant, animal-derived
Primary Device ID20386040015247
NIH Device Record Keyb648580b-e530-433b-8b3e-c86071ccf0da
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoundation
Version Model Number27-500-100
Catalog Number27-500-100
Company DUNS005473608
Company NameGc America Inc.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Dimensions

Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter
Length25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100386040015243 [Primary]
GS120386040015247 [Package]
Contains: 00386040015243
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

LYCBone grafting material, synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

On-Brand Devices [Foundation]

20386040015254Collagen-Based Bone Filling Augmentation Material
20386040015247Collagen-Based Bone Filling Augmentation Material

Trademark Results [Foundation]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FOUNDATION
FOUNDATION
98023366 not registered Live/Pending
Foundation Medicine, Inc.
2023-06-01
FOUNDATION
FOUNDATION
97817578 not registered Live/Pending
Jane Pauley Community Health Center, Inc.
2023-03-01
FOUNDATION
FOUNDATION
97722337 not registered Live/Pending
CJC Off Road LLC
2022-12-19
FOUNDATION
FOUNDATION
97348029 not registered Live/Pending
B. R. Funsten & Company
2022-04-05
FOUNDATION
FOUNDATION
97347532 not registered Live/Pending
B. R. Funsten & Company
2022-04-05
FOUNDATION
FOUNDATION
97274293 not registered Live/Pending
Acres Manufacturiong Company
2022-02-18
FOUNDATION
FOUNDATION
90754069 not registered Live/Pending
ION Geophysical, Corp.
2021-06-04
FOUNDATION
FOUNDATION
90663483 not registered Live/Pending
Nvision Biomedical Technologies, Inc.
2021-04-22
FOUNDATION
FOUNDATION
90392560 not registered Live/Pending
Frankford Leather Co., Inc.
2020-12-18
FOUNDATION
FOUNDATION
90392525 not registered Live/Pending
Frankford Leather Co., Inc.
2020-12-18
FOUNDATION
FOUNDATION
90369348 not registered Live/Pending
Acres Technology
2020-12-09
FOUNDATION
FOUNDATION
90185648 not registered Live/Pending
Skydance Productions, LLC
2020-09-16

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