FDA.reportPublic FDA data

Osseoflex®

Primary DI
00884450387399
Brand
Osseoflex®
Company
Merit Medical Systems, Inc.
Model
00884450387399
Catalog number
OT-0222/B
Published
2019-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10884450387396PackageGS11In Commercial Distribution
00884450387399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445038739610884450387396
00884450387399008844503873998844503873990884450387399

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.

Device Sizes#

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

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450148228Merit Medical®Initial ReleaseK09-09226C2026-08-19
00884450428474Merit Medical®Initial ReleaseK10-04389A2026-08-19
00884450432365Merit Medical®Initial ReleaseK10-05106A2026-08-18
00884450476079CorVocet™BCORA1410S2026-08-18
00884450476093CorVocet™BCORA14152026-08-18
00884450838211Prelude Roadster™APG7F45SX2026-08-18
00884450457535C2 CryoBalloon™AFG-10402026-08-17
00884450458204DuraMax®BH7871030280312026-08-17
00884450531969Prelude Roadster™00884450531969PG6F45S2022-07-20
00884450122471Merit Medical®Initial ReleaseK08-01887B2026-08-14
00884450428245Merit Medical®Initial ReleaseK10-05700A2026-08-15
00884450467220Merit Medical®Initial ReleaseK09-05248N2026-08-14
00884450488775Merit Medical®Initial ReleaseK10T-04423Q2026-08-14
00884450488843Merit Medical®Initial ReleaseK12T-127422026-08-15
00884450110164Merit Disposal Depot™Initial ReleaseK10-00230D2026-08-07
00884450487402Merit Medical®Initial ReleaseK01-083682026-08-07
00884450500859Merit Medical®Initial ReleaseK09-10938D2026-08-08
00884450421994Merit Medical®Initial ReleaseK12-12513B2026-08-01
00884450447093Merit Medical®Initial ReleaseK09-02692J2026-08-01
00884450468951DuraMax®CH7871030282012026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.NDN2026-07-27
08800038029323SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03