FDA.reportPublic FDA data

N-Force Blue ™

Primary DI
00889024563278
Brand
N-Force Blue ™
Company
Etex Corporation
Model
IN050-7
Catalog number
IN050-7
Published
2019-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141245000ETEX MIXING AND DELIVERY SYSTEMEtex Corporation2014-07-09FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024563278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024563278008890245632788890245632780889024563278

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft delivery kitA collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003489500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
622221141
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024205444AccuFill®201.050201.0502015-11-02
00889024406476AccuFill®201.030201.0302015-11-02
00889024501225AccuFill ® PreFill2061302061302019-12-18
00889024501232AccuFill ® PreFill2061502061502019-12-18
00889024563285N-Force Blue ™IN050-8IN050-82019-12-16
00889024205567CarriGen ® 76-60362015-10-24
00889024432826CarriGen76-603576-60352016-06-02
00889024205529EquivaBone ® 76-60272015-10-24
00889024205536EquivaBone ® 76-60212015-10-24
00889024205543EquivaBone ® 76-60222015-10-24
00889024205550EquivaBone ® 76-60412015-10-24
00889024205505Beta-bsm ® 76-60252015-10-24
00889024205512Beta-bsm ® 76-60162015-10-24
00889024499690Flow-FX271-002571-00252019-01-23
00889024499706Flow-FX271-005071-00252019-01-23
00889024563254N-Force BlueIN050-6IN050-62019-01-28
00889024563261N-Force BlueIN050-5IN050-52019-01-28
00889024205451Gamma-bsm ®76-60012015-10-24
00889024205468Gamma-bsm ®76-60232015-10-24
00889024205475Gamma-bsm ®76-60052015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02