FDA.reportPublic FDA data

Osseoflex®

Primary DI
00884450328293
Brand
Osseoflex®
Company
Merit Medical Systems, Inc.
Model
00884450328293
Catalog number
OCP-0241/A
Published
2018-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450328293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450328293008844503282938844503282930884450328293

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable bone tampA catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Premarket exempt
true
Kit
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22
00884450421581Merit Medical®Initial ReleaseK12-08733A2026-07-21
00884450795705Merit Medical®Initial ReleaseK12-10248A2026-07-21
00884450457382C2 CryoBalloon™AFG-10132026-07-20
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956528659CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-20
10198956400856CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-16
10198956515215CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-06
10198956457898CARDINAL HEALTHCardinal Health 200, LLCOJV2026-06-01
10195594797751CARDINAL HEALTHCardinal Health 200, LLCOJV2023-08-02
10197106059609CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-19
10197106162712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-05
10197106244470CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-16
10197106245224CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-15
10197106163962CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-14
10197106229132CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-05
10197106221785CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106236727CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106170540CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-18
10197106188712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-11
10197106110263CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-02
10197106243039CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-01
10197106244432CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-28
10197106246665CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-27
10197106220146CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-21
10197106226667CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-20
10197106229484CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106234334CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106240816CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106154281CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106182659CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106056516CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106136508CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106196533CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106175644CARDINAL HEALTHCardinal Health 200, LLCOJV2023-03-29