FDA.reportPublic FDA data

Backpack AF

Primary DI
00850009685353
Brand
Backpack AF
Company
Ventris Medical
Model
BAF-002
Device description
Backpack AF 18mm x 100mm (large)
Published
2026-01-02
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
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009685377PackageGS12In Commercial Distribution
00850009685353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009685377008500096853778500096853770850009685377
00850009685353008500096853538500096853530850009685353

GMDN Terms#

Term, Definition table
TermDefinition
Human-derived demineralized bone matrix implantAn implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
949-706-5551info@ventrismedical.com

Regulatory Flags#

DUNS number
081127567
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
00850009685346Backpack AFBAF-0012026-01-02
00850009685117contour BA STRIPCBA-1600CBA-16002023-09-21
00850009685124contour BA STRIPCBA-800CBA-8002023-09-21
00850009685131contour BA STRIPCBA-400CBA-4002023-09-21
00850009685261contour BA STRIPCBA-1000CBA-10002023-09-21
00850009685278contour BA PUCKCBA-500CBA-5002023-09-21
00850009685285contour BA PUCKCBA-200CBA-2002023-09-21
00850009685384AmplifyAMP-0182025-07-29
00850009685292Connext Surgical Matrix CNX-015CNX-0152024-04-22
00850009685308Connext Surgical Matrix CNX-030CNX-0302024-04-22
00850009685315Connext Surgical Matrix CNX-045CNX-0452024-04-22
00850009685322Connext Surgical Matrix CNX-015CNX-0152024-04-24
00850009685339Connext Surgical Matrix CNX-030CNX-0302024-04-24
00850009685230AmplifyAMP-0372024-07-26
00850009685247AmplifyAMP-0752024-07-26
00850009685254AmplifyAMP-1502024-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11
00085412654386ALTAPOREApatech LtdMQV2019-12-11
00085412654393ALTAPOREApatech LtdMQV2019-12-11
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2019-03-29
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512826MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994986467MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986474MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986481MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986498MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986504MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986511MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986528MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986535MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986542MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00613994986559MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00643169103986MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00643169103993MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01
00643169104006MAGNIFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.MQV2015-12-01