FDA.reportPublic FDA data

NOVAE

Primary DI
03662200012954
Brand
NOVAE
Company
SOC ETUDES RECHERCHES FABRICATION
Model
EPMP6
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXEDoppler, Fetal, Ultrasound
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXEDoppler, Fetal, UltrasoundObstetrics/Gynecology2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662200012954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662200012954036622000129543662200012954

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
282651413
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662200033126Trays associated with hip instrumentsRA999900622024-09-17
03662200005796CI ECI 41/22,2 E2015-09-01
03662200005802CI ECI 43/22,2 E2015-09-01
03662200005819CI ECI 45/22,2 E2015-09-01
03662200005826CI ECI 47/22,2 E2015-09-01
03662200005833CI ECI 49/22,2 E2015-09-01
03662200005840CI ECI 51/22,2 E2015-09-01
03662200005857CI ECI 53/22,2 E2015-09-01
03662200005864CI ECI 55/22,2 E2015-09-01
03662200005871CI ECI 57/22,2 E2015-09-01
03662200005888CI ECI 59/22,2 E2015-09-01
03662200005895CI ECI 61/22,2 E2015-09-01
03662200005901CI ECI 63/22,2 E2015-09-01
03662200005918CI ECI 65/22,2 E2015-09-01
03662200005925CI ECI 67/22,2 E2015-09-01
03662200005932CI ECI 69/22,2 E2015-09-01
03662200005963CI ECI 47/28 E2015-09-01
03662200005970CI ECI 49/28 E2015-09-01
03662200005987CI ECI 51/28 E2015-09-01
03662200005994CI ECI 53/28 E2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867550292Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550308Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550315Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
04054896000831Control GaugesSilony Medical GmbHLXH2026-09-18
04054896000855Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000862Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000879Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000886Forceps and ClampsSilony Medical GmbHLXH2026-09-18
04054896000893(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18