Ocelot

Primary DI
10860009899800
Brand
Ocelot
Company
Tendonova Corporation
Model
DU1F30L
Device description
TendoNova Ocelot DU1F30L Disposable Unit- 30mm
Published
2023-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10860009899800PackageGS15In Commercial Distribution
00860009899803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000989980010860009899800
00860009899803008600098998038600098998030860009899803

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
Length30Millimeter

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00860008843548OcelotTDS-10002023-03-10
10860008843507OcelotDU1F60L2023-03-07
00860008843517OcelotRDU-10002023-03-07
00860008843524OcelotCHG-1002023-03-07
10860009899817OcelotDU1F80L2023-03-07

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Primary DI, Brand, Company table
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