FDA.reportPublic FDA data

DBX®

Primary DI
W4184228010T0473
Brand
DBX®
Company
Musculoskeletal Transplant Foundation, Inc.
Model
228010
Catalog number
228010
Device description
DBX Putty 1cc
Published
2016-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXPMethyl Methacrylate For Cranioplasty
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
W4184228010T0473PrimaryICCBBA0

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
800-433-6576RA_Licenses@mtf.org

Regulatory Flags#

DUNS number
187560545
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
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
true
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
W4184058150T0474DBX®0581500581502026-06-05
W4184028005T0476DBX®0280050280052016-02-19
W4184028010T0476DBX®0280100280102016-02-19
W4184028050T0476DBX®0280500280502016-02-19
W4184028100T0476DBX®0281000281002016-02-19
W4184030005T0473DBX®0300050300052016-02-19
W4184030010T0473DBX®0300100300102016-02-19
W4184030025T0473DBX®0300250300252016-02-19
W4184038005T0473DBX®0380050380052016-02-19
W4184038010T0473DBX®0380100380102016-02-19
W4184038025T0473DBX®0380250380252016-02-19
W4184038050T0473DBX®0380500380502016-02-19
W4184038100T0473DBX®0381000381002016-02-19
W4184048150T0479DBX®0481500481502016-02-19
W4184058025T0474DBX®0580250580252016-02-19
W4184058050T0474DBX®0580500580502016-02-19
W4184058100T0474DBX®0581000581002016-02-19
W4184058200T0474DBX®0582000582002016-02-19
W4184068025T0473DBX®0680250680252016-02-19
W4184068050T0473DBX®0680500680502016-02-19

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
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
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