FDA.reportPublic FDA data

A-Oss®

Primary DI
00814913024257
Brand
A-Oss®
Company
HIOSSEN, INC.
Model
AOSN200SV
Published
2016-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151542000A-OssHiossen, Inc.2016-08-03NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814913024257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814913024257008149130242578149130242570814913024257

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083090
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126045911ET IV Fixture Ultra-Wide NH Regular Pre-MountedAET4R6015B2026-04-10
00810126045294ET IV Fixture NH Regular Pre-MountedAET4M3508B2026-04-07
00810126045300ET IV Fixture SA Regular Pre-MountedAET4M3508S2026-04-07
00810126045317ET IV Fixture NH Regular Pre-MountedAET4M3510B2026-04-07
00810126045324ET IV Fixture SA Regular Pre-MountedAET4M3510S2026-04-07
00810126045331ET IV Fixture NH Regular Pre-MountedAET4M3511B2026-04-07
00810126045348ET IV Fixture SA Regular Pre-MountedAET4M3511S2026-04-07
00810126045355ET IV Fixture NH Regular Pre-MountedAET4M3513B2026-04-07
00810126045362ET IV Fixture SA Regular Pre-MountedAET4M3513S2026-04-07
00810126045379ET IV Fixture NH Regular Pre-MountedAET4M3515B2026-04-07
00810126045386ET IV Fixture SA Regular Pre-MountedAET4M3515S2026-04-07
00810126045393ET IV Fixture NH Regular Pre-MountedAET4R4007B2026-04-07
00810126045409ET IV Fixture SA Regular Pre-MountedAET4R4007S2026-04-07
00810126045416ET IV Fixture NH Regular Pre-MountedAET4R4008B2026-04-07
00810126045423ET IV Fixture SA Regular Pre-MountedAET4R4008S2026-04-07
00810126045430ET IV Fixture NH Regular Pre-MountedAET4R4010B2026-04-07
00810126045447ET IV Fixture SA Regular Pre-MountedAET4R4010S2026-04-07
00810126045454ET IV Fixture NH Regular Pre-MountedAET4R4011B2026-04-07
00810126045461ET IV Fixture SA Regular Pre-MountedAET4R4011S2026-04-07
00810126045478ET IV Fixture NH Regular Pre-MountedAET4R4013B2026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806387896760Renew-Cera, (BoneMedik-DM 0.3~0.5mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896777Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896784Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896791Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896807Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896814Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896821Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896838Renew-Cera, (BoneMedik-DM 0.5~1.0mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896845Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896852Renew-Cera, (BoneMedik-DM 0.3 ~ 0.5 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896869Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896876Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08800039000000THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000017THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000024THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000031THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000048THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000055THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000062THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000079THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000086THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000093THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000109THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000116THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000123THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000130THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000147THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000154THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000161THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000178THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15