OsseoSeal

GUDID 08800048502236

Resorbable Collagen Membrane

HYUNDAI BIOLAND Co., Ltd.

Collagen dental regeneration membrane
Primary Device ID08800048502236
NIH Device Record Key254a2fab-d8e2-43ca-b5df-c6778f543097
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsseoSeal
Version Model NumberOS1520
Company DUNS688235061
Company NameHYUNDAI BIOLAND Co., Ltd.
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

Device Dimensions

Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108800048502236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-16
Device Publish Date2022-03-08

On-Brand Devices [OsseoSeal]

08800048502250Resorbable Collagen Membrane
08800048502243Resorbable Collagen Membrane
08800048502236Resorbable Collagen Membrane

Trademark Results [OsseoSeal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSSEOSEAL
OSSEOSEAL
97132419 not registered Live/Pending
KB Dental Products INC
2021-11-18

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