iNSitu™ Hip System

Primary DI
00816127023378
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-99-0104
Device description
Macro Tray
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816127023378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127023378008161270233788161270233780816127023378

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
330-733-7600info@theken.us

Regulatory Flags#

DUNS number
060211165
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816127025518TheRay Collared and Collarless Femoral Stem12-12-00002025-09-02
00816127025525TheRay Collared and Collarless Femoral Stem12-12-00012025-09-02
00816127025532TheRay Collared and Collarless Femoral Stem12-12-00022025-09-02
00816127025549TheRay Collared and Collarless Femoral Stem12-12-00032025-09-02
00816127025556TheRay Collared and Collarless Femoral Stem12-12-00042025-09-02
00816127025563TheRay Collared and Collarless Femoral Stem12-12-00052025-09-02
00816127025570TheRay Collared and Collarless Femoral Stem12-12-00062025-09-02
00816127025587TheRay Collared and Collarless Femoral Stem12-12-00072025-09-02
00816127025594TheRay Collared and Collarless Femoral Stem12-12-00082025-09-02
00816127025600TheRay Collared and Collarless Femoral Stem12-12-00092025-09-02
00816127025617TheRay Collared and Collarless Femoral Stem12-12-00102025-09-02
00816127025648TheRay Collared and Collarless Femoral Stem12-13-00002025-09-02
00816127025655TheRay Collared and Collarless Femoral Stem12-13-00012025-09-02
00816127025662TheRay Collared and Collarless Femoral Stem12-13-00022025-09-02
00816127025679TheRay Collared and Collarless Femoral Stem12-13-00032025-09-02
00816127025686TheRay Collared and Collarless Femoral Stem12-13-00042025-09-02
00816127025693TheRay Collared and Collarless Femoral Stem12-13-00052025-09-02
00816127025709TheRay Collared and Collarless Femoral Stem12-13-00062025-09-02
00816127025716TheRay Collared and Collarless Femoral Stem12-13-00072025-09-02
00816127025723TheRay Collared and Collarless Femoral Stem12-13-00082025-09-02

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