FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
10653405055402
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD1937
Catalog number
CD1937
Device description
5mm Audible Dilating Trocar and Cannula
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992250000CORE AUDIBLE TROCAR IICore Dynamics, Inc.1999-09-24GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405055402PackageGS110In Commercial Distribution
20653405055409PrimaryGS10
00653405055405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340505540210653405055402
2065340505540920653405055409
00653405055405006534050554056534050554050653405055405

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
10
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422110MillenniumAvalign Technologies, Inc.GCJ2026-07-24
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00817401029178EndoplusEndoplusHET2026-07-08
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24