FDA.reportPublic FDA data

AVAmax

Primary DI
10885403002113
Brand
AVAmax
Company
CAREFUSION 2200, INC
Model
VMX00CT
Catalog number
VMX00CT
Device description
AVAmax PLUS Bone Cement Delivery System
Published
2017-06-12
Public version status
Update
Distribution status
Not 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
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403002111PackageGS15Not in Commercial Distribution
10885403002113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540300211150885403002111
1088540300211310885403002113

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Flash Point 50°F (10°C). Keep away from heat, sparks, open flame, and other sources of ignition. Store in a dark, dry place below 77°F (25°C) and protect from light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
832696038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

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Primary DI, Brand, Company table
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10884450731700StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450731724StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450847296StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450847302StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450587772StabiliT®Merit Medical Systems, Inc.NDN2026-02-18
03701505801204DynamoTEKNIMEDNDN2026-02-02
03701505801211DynamoTEKNIMEDNDN2026-02-02
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03701505801235DynamoTEKNIMEDNDN2026-02-02
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00815212026942BKP-10-12.0-15.0-BIzi Medical Products, LLCNDN2025-01-08
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00889095358230CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00197157019334Zavation CURVED CURETTEZavation LLCNDN2024-11-13
00842166121546Zavation ZVplasty System AssemblyZavation LLCNDN2024-11-01
07613327638448OmnicurveSTRYKER CORPORATIONNDN2024-09-03
00815212026911KIT:BALLOON AND BONE FILLERIzi Medical Products, LLCNDN2024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLIzi Medical Products, LLCNDN2024-08-28
10815212026895OsteoPearl Vertebral Balloon (15mm), 10GIzi Medical Products, LLCNDN2024-08-05
00815212026904OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10GIzi Medical Products, LLCNDN2024-08-05
00197157019730ZavationZavation LLCNDN2024-07-01
00197157019747ZavationZavation LLCNDN2024-07-01