FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
20653405043277
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD801
Catalog number
CD801
Device description
5mm Laparoscopic Kittner, Blunt Dissector 40 cm Length
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955490000LAPAROSCOPIC KNITTERCore Dynamics, Inc.1996-01-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405043270PackageGS15In Commercial Distribution
20653405043277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065340504327010653405043270
2065340504327720653405043277

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic blunt dissectorA sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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20653405990427Infinity™DB-0808DB-08082026-06-10
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20653405990458Infinity™DB-0610DB-06102026-06-10
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