FDA.reportPublic FDA data

Ocelot

Primary DI
00860008843500
Brand
Ocelot
Company
Tendonova Corporation
Model
DU1F60L
Device description
TendoNova Ocelot DU1F60L Disposable Unit- 60mm
Published
2023-03-07
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

Product Codes#

Code, Name table
CodeName
LFLInstrument, ultrasonic surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212049000Oclet TDS 1000Tendonova Corporation2022-03-08LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860008843507PackageGS15In Commercial Distribution
00860008843500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000884350710860008843507
00860008843500008600088435008600088435000860008843500

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece tip, single-useA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
115587907
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009899872TendoNova OcelotDU1F30L-K2023-12-07
00860009899827TendoNova OcelotDU5F80L-K2023-12-05
00860009899834TendoNova OcelotDU5F30L-K2023-12-05
00860009899841TendoNova OcelotDU5F60L-K2023-12-05
00860009899858TendoNova OcelotDU1F80L-K2023-12-05
00860009899865TendoNova OcelotDU1F60L-K2023-12-05
00860008843548OcelotTDS-10002023-03-10
00860009899803OcelotDU1F30L2023-03-07
00860009899810OcelotDU1F80L2023-03-07
10860008843507OcelotDU1F60L2023-03-07
00860008843517OcelotRDU-10002023-03-07
00860008843524OcelotCHG-1002023-03-07
10860009899800OcelotDU1F30L2023-03-07
10860009899817OcelotDU1F80L2023-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-07-14
10381780533870CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
10381780533894CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
07613327576627Sonopet iQSTRYKER CORPORATIONLFL2023-03-24
10381780536369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780533863CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-09-06
07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
10884521807884SonicisionCovidien LPLFL2020-06-29
07613327298635Sonopet iQSTRYKER CORPORATIONLFL2019-05-10
10381780466215CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
10381780466383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
07613327422382Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422399Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422405Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422412Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422429Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422436Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422443Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422450Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422467Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422474Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422481Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422498Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422504Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422511Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422528Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
10381780126416CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-02-08