Ocelot

Primary DI
00860008843548
Brand
Ocelot
Company
Tendonova Corporation
Model
TDS-1000
Device description
TDS-1000 TendoNova Ocelot Nano System
Published
2023-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00860008843548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008843548008600088435488600088435480860008843548

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece, reusableA hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The handpiece may also serve as a conduit for irrigation and aspiration during surgery. It is typically in the form of a pen/pencil or elongated probe with permanently attached cables. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
115587907
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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