FDA.report

SHARP NEEDLES, DermiSync

Primary DI
08800062763736
Brand
SHARP NEEDLES, DermiSync
Company
YONG CHANG Corporation
Model
YC034002
Published
2026-02-23
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K151090000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K151090000CPL Insulin Pen NeedleCpl Co., Ltd.2016-09-21FMI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800062763736PrimaryGS10

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
201) 815-1740jamie@plandocsusa.com

Regulatory Flags

DUNS number
694805976
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
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08809892879365PD NANO CANNULAS2270T21252025-01-22
08809892879938PD NANO CANNULAS2250T21252025-01-22
08800062795201MINT MICROCANNULAMC18502022-11-07

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