FDA.reportPublic FDA data

Nuvis

Primary DI
00853816008032
Brand
Nuvis
Company
INTEGRATED ENDOSCOPY, INC.
Model
IE58OB
Catalog number
IE58OB
Device description
The obturator is a solid stainless steel needle used with cannula to close or block up the cannula opening. The obturator will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure.
Published
2020-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853816008032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853816008032008538160080328538160080320853816008032

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, reusableA single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
127632602
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08538160080010Nuvis140-4010-1140-4010-12018-02-08
00853816008001NuvisIE4030IE40302020-03-30
10853816008008NuvisIE4030-10IE4030-102020-03-30
00853816008018NuvisIE58CAN-2IE58CAN-22020-03-30
00853816008025NuvisIE58CAN-1IE58CAN-12020-03-30
00853816008049NuvisIE58TRIE58TR2020-03-30
08538160080027Nuvis140-4010-1140-4010-12018-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00857915007798Retra Uni Gen 1 SingleA.M. SURGICAL, INC.NBH2026-06-04
10857915007030RETRA Single - GEN 2 DepricatedA.M. SURGICAL, INC.NBH2026-06-04
00857915007026Scope AdapterA.M. SURGICAL, INC.NBH2026-06-01
04059453163318Hermann Medizintechnik GmbHHermann Medizintechnik GmbHNBH2026-05-29
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