FDA.reportPublic FDA data

CopiOs® Bone Void Filler Sponge

Primary DI
00812337021067
Brand
CopiOs® Bone Void Filler Sponge
Company
DSM BIOMEDICAL, INC.
Model
20101-03
Catalog number
00-1103-010-10
Published
2015-09-17
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

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
00812337021067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337021067008123370210678123370210670812337021067

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Regulatory Flags#

DUNS number
131107757
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
false
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
M263W25000WizardBio Resorbable Calcium Phosphate Cement21004-05W250002019-01-02
00812337020442Drillable Bone Void Filler21005-0307.705.003S2023-01-11
00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
M26300110301005CopiOs® Bone Void Filler Sponge20101-0200-1103-010-052015-09-17
M26300110301010CopiOs® Bone Void Filler Sponge20101-0300-1103-010-102015-09-17
M26300110302001CopiOs® Bone Void Filler Paste20102-0100-1103-020-012015-09-17
M26300110302005CopiOs® Bone Void Filler Paste20102-0200-1103-020-052015-09-17
M26300110302010CopiOs® Bone Void Filler Paste20102-0300-1103-020-102015-09-17
M2630011301001CopiOs® Bone Void Filler Sponge20101-0100-1103-010-012015-09-17
M2630700582001CopiOs® Bone Void Filler Sponge20100-0107.00582.0012015-09-17
M2630700582003CopiOs® Bone Void Filler Sponge20100-0207.00582.0032015-09-17
M2630700582004CopiOs® Bone Void Filler Sponge20100-0307.00582.0042015-09-17
00812337020435BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc21003-04ABS-31012023-05-09
M263300700402DSM Biomedical Dental Bone Graft30070-042021-10-20
M263300700503DSM Biomedical Dental Bone Graft30070-052021-10-20
M263300700604DSM Biomedical Dental Bone Graft30070-062021-10-20
M263300700705DSM Biomedical Dental Bone Graft30070-072021-10-20
M263300700806DSM Biomedical Dental Bone Graft30070-082021-10-20
M263300700907DSM Biomedical Dental Bone Graft30070-092021-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080243183Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243237Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccSurgentec, LLCMQV2025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccSurgentec, LLCMQV2025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccSurgentec, LLCMQV2025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccSurgentec, LLCMQV2025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccSurgentec, LLCMQV2025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccSurgentec, LLCMQV2025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00850391007245Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007306Montage Flowable Settable Bone PasteABYRX, INC.MQV2023-11-16
00850391007313Montage Flowable Settable Bone PasteABYRX, INC.MQV2023-11-16
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00813954023915OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2020-09-15
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11