InterOss®

Primary DI
00852072007087
Brand
InterOss®
Company
SIGMAGRAFT, INC.
Model
IOLG200
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K151209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151209000InterOssSigmagraft, Inc.2015-11-06NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852072007087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852072007087008520720070878520720070870852072007087

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, animal-derivedA bioabsorbable, implantable device made primarily of animal-derived materials (e.g., bovine, porcine) intended to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities and defects. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight0

Contacts#

Phone, Email table
PhoneEmail
+1(714)525-0114quality.sigmagraft@sigmagraft.com

Regulatory Flags#

DUNS number
078893672
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852072007001InterOssIOSG0152023-07-13
00852072007421InterOss CollagenIOC-0502023-05-15
00852072007438InterOss CollagenIOC-1002023-05-15
00852072007445InterOss CollagenIOC-2502023-05-15
00852072007452InterOss CollagenIOC-3502023-05-15
00852072007469InterOss CollagenIOC-5002023-05-15
00852072007476InterOss CollagenIOC-P1502023-05-15
00852072007483InterOss CollagenIOC-P2502023-05-15
00852072007490InterOss CollagenIOC-P4002023-05-15
00852072007506InterOss CollagenIOC-P4502023-05-15
00852072007209PuraXen+XEN-250-0252023-03-01
00852072007568PuraXen+XEN-250-0502023-03-01
00852072007575PuraXen+XEN-250-1002023-03-01
00852072007582PuraXen+XEN-250-2002023-03-01
00852072007599PuraXen+XEN-1000-0502023-03-01
00852072007605PuraXen+XEN-1000-1002023-03-01
00852072007612PuraXen+XEN-1000-2002023-03-01
00852072007629PuraXen+XEN-S-250-0252023-03-01
00852072007636PuraXen+XEN-S-250-0502023-03-01
00852072007643PuraXen+XEN-S-250-1002023-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.NPM2025-09-05
00813954026732PuraFILLCOLLAGEN MATRIX, INC.NPM2025-03-26
00813954026749PuraFILLCOLLAGEN MATRIX, INC.NPM2025-03-26
00813954026183REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026190REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026138EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
00813954026145EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
00614950028443OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028450OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028467OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028474OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028481OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028498OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028504OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028511OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00813954025315RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00813954025322RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00614950027934MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027941MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027958MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027965MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027972MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027989MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950027996MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028009MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028016MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028023MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028030MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27
00614950028047MinerOss® XACE SURGICAL SUPPLY CO., INC.NPM2022-10-27