FDA.report

CORE DYNAMICS

Primary DI
10653405043324
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD950
Catalog number
CD950
Device description
CORE DYNAMICS 5 MM ASPIRATION/INJECTION NEEDLE 16 GAUGE, 40 CM LENGTH
Published
2021-10-14
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

Related Records

Contact Domains

Product Codes

CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653405043324PackageGS11In Commercial Distribution
20653405043321PrimaryGS10
00653405043327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340504332410653405043324
2065340504332120653405043321
00653405043327006534050433276534050433270653405043327

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
5
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company

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10845854041116POWERPROPRO2000PRO20002026-03-24
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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
20653405024948CONMEDR324IIRA2R324IIRA22026-03-24
20653405034701CONMEDD8550D85502026-03-24

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30192253036880MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036897MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036907MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036934MonojectCardinal Health 200, LLCGAA2026-03-23
30192253036941MonojectCardinal Health 200, LLCGAA2026-03-23
50192253036952MonojectCardinal Health 200, LLCGAA2026-03-23
50198956355451CARDINAL HEALTHCardinal Health 200, LLCGAA2026-03-19
MHC18018250EasyTouchMHC MEDICAL PRODUCTS, LLCGAA2026-03-17
00810235030860US Accessory KitMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030877US Rigid Needle with Support Cannula- Double BevelMERZ NORTH AMERICA, INC.GAA2026-03-05
00810235030884US Rigid Injection Needle with Huber PointMERZ NORTH AMERICA, INC.GAA2026-03-05
20850083784403Comfort EZS.D.I. USA, INC.GAA2026-02-13
50192253036860MonojectCardinal Health 200, LLCGAA2026-02-10
50192253036976MonojectCardinal Health 200, LLCGAA2026-02-10
50192253025260MonojectCardinal Health 200, LLCGAA2026-01-16
50198956310047CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-26
50198956290554CARDINAL HEALTHCardinal Health 200, LLCGAA2025-12-17
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04046964943232NAB. BRAUN MEDICAL INC.GAA2025-12-02
04046964941221Filter Straw®B. BRAUN MEDICAL INC.GAA2025-12-02
50198956273182CARDINAL HEALTHCardinal Health 200, LLCGAA2025-11-14
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08800176592673WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592680WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592697WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592703WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08