FDA.reportPublic FDA data

TruForm

Primary DI
08809204338702
Brand
TruForm
Company
Hans Biomed Corp.
Model
FP010DEMO
Device description
1.0cc(DEMONSTRATION)
Published
2017-07-18
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
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound
NUNBone Grafting Material, Human Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2
NUNBone Grafting Material, Human SourceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809204338702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809204338702088092043387028809204338702

Regulatory Flags#

DUNS number
689512625
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
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
08809963474109MINT MONO SuturesMINT 50HN2538A2026-10-20
08809963474116MINT MONO SuturesMINT 50HN2938A2026-10-20
08809963474123MINT MONO SuturesMINT 50HN3038A2026-10-20
08809963478428MINT MONO SuturesMINT 90HN2760A2026-10-20
08809963478435MINT MONO SuturesMINT 50HN2738A2026-10-20
08809963478459MINT MONO SuturesMINT 70HN2550A2026-10-20
08809204338498ExponentEXP002017-03-09
08809204338580TruForm+TFP003DEMO2017-07-18
08809204338597TruForm+TFP005DEMO2017-07-18
08809204338603TruForm+TFP010DEMO2017-07-18
08809204338610TruForm+TFP030DEMO2017-07-18
08809204338627TruForm+TFP050DEMO2017-07-18
08809204338634TruForm+TFP100DEMO2017-07-18
08809204338641TruForm+TFG010DEMO2017-07-18
08809204338658TruForm+TFG030DEMO2017-07-18
08809204338665TruForm+TFG050DEMO2017-07-18
08809204338672TruForm+TFG100DEMO2017-07-18
08809204338689TruFormFP003DEMO2017-07-18
08809204338696TruFormFP005DEMO2017-07-18
08809204338719TruFormFP030DEMO2017-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080243183Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
00850080243183Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243237Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
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
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccRti Surgical, Inc.NUN2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccRti Surgical, Inc.NUN2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccRti Surgical, Inc.NUN2024-05-27