Backpack AF

GUDID 00850009685353

Backpack AF 18mm x 100mm (large)

Ventris Medical

Bone matrix implant, human-derived
Primary Device ID00850009685353
NIH Device Record Keyb345dc7d-2c23-427f-8931-3489d0439f4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBackpack AF
Version Model NumberBAF-002
Company DUNS081127567
Company NameVentris Medical
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com
Phone949-706-5551
Emailinfo@ventrismedical.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850009685353 [Primary]
GS100850009685377 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-12
Device Publish Date2026-01-02

On-Brand Devices [Backpack AF]

00850009685353Backpack AF 18mm x 100mm (large)
00850009685346Backpack AF 18mm x 50mm (medium)

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