FDA.report

CORE DYNAMICS

Primary DI
20653405045370
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD1975
Catalog number
CD1975
Device description
5mm & 10/12mm Trocar/Cannula Procedure Kit
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20653405045370PackageGS16Not in Commercial Distribution
10653405045373PrimaryGS10
00653405045376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340504537020653405045370
1065340504537310653405045373
00653405045376006534050453766534050453760653405045376

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
6
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 DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
04251303822769BLUEENDOTROKAMED GmbHHET2026-03-03
04251303824961BLUEENDOTROKAMED GmbHHET2026-02-27
04251303824978BLUEENDOTROKAMED GmbHHET2026-02-27
00817401029130EndoplusEndoplusHET2026-02-06
00817401029123EndoplusEndoplusHET2026-01-16
00817401029116EndoplusEndoplusHET2025-12-19
00198506086892ELMED INCORPORATEDELMED INCORPORATEDHET2025-11-25
G465FG16000Non-ICG 5mm Laparoscope (0 Deg)Smartsurgn Inc.HET2025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)Smartsurgn Inc.HET2025-08-27
00198506044229ELMED INCORPORATEDELMED INCORPORATEDHET2025-08-15
00198506084256ELMED INCORPORATEDELMED INCORPORATEDHET2025-07-24
04048223128121Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
04048223128145Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
EAMIICT50100i-Cut Power SupplyAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50110i-CutAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50500i-Cut Power Supply Type AAMI Agency for Medical Innovations GmbHHET2025-05-05
00198506082542ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-30
00198506026096ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506026119ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027215ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027222ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00817401029109EndoplusEndoplusHET2025-04-10
00198506081330ELMED INCORPORATEDELMED INCORPORATEDHET2025-03-17
00817401029093EndoplusEndoplusHET2025-03-14