FDA.reportPublic FDA data

Orthoss®

Primary DI
07610221013111
Brand
Orthoss®
Company
Geistlich Pharma AG
Model
500502
Catalog number
-
Published
2019-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07610221013111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07610221013111076102210131117610221013111

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth2Centimeter
Height1.3Centimeter
Width2Centimeter

Regulatory Flags#

DUNS number
480781728
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07610221017737Derma-Gide®5020102026-06-01
07610221017829Device 300423 Granules5021902026-06-01
07610221017836Device 300423 Granules5021912026-06-01
07610221017843Device 300423 Granules5021922026-06-01
07610221017850Device 300423 Granules5021932026-06-01
07610221017867Device 300423 Granules5021942026-06-01
07610221017874Device 300423 Granules5021952026-06-01
07610221017881Device 300423 Granules5021962026-06-01
07610221017898Device 300423 Granules5021972026-06-01
07610221017904Device 300423 Granules5021982026-06-01
07610221017911Device 300423 Granules5021992026-06-01
07610221017928Device 300423 Granules5022002026-06-01
07610221017645Bionnovation Gide XP5021702026-05-08
07610221017652Bionnovation Gide XP5021712026-05-08
07610221017669Bionnovation Gide XP5021722026-05-08
07610221017201Geistlich Bio-Gide®5021132026-04-09
07610221017126Derma-Gide®5004272025-07-01
07610221017133Derma-Gide®5004742025-07-01
07610221017140Derma-Gide®5004802025-07-01
07610221015481Geistlich Fibro-Gide®5008382022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856879006519FIBERGRAFT AeridyanMedos International SàrlMQV2026-09-29
00812593023188osteoSPAN GranulesBiogennix, LLCMQV2026-07-24
00812593023195SUMMIT Matrix Granules 10ccBiogennix, LLCMQV2026-07-24
00812593023201SUMMIT Matrix Granules 30ccBiogennix, LLCMQV2026-07-24
00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05