SHINCHANG MEDICAL CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96161573003169040SHINCHANG MEDICAL CO., LTD.1N2027-01-01144, 1gongdan-ro 6-gil Gumi-si Gyeongbuk KR 39385

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08800109007038DMject Insulin Syringe - 1. Insulin Syringe2. Intended use : For the injection of insulin and primarily in human.3. Instructions for use1) To expose plunger, remove large orange cap.2) To expose needle, pull small orange cap STRAIGHT off, being careful not to bend needle.3) To measure correct dosage align top edge of plunger tip with your dosage mark on the syringe scale.4) Use syringe ONCE only. To prevent misuse after injection, destroy syringe and needle.4. WarningFor patients who mix two types of insulin, do not change(a) the order of mixing that the physician has prescribed or(b) the model and brand of the syringe without first consulting your physician or pharmacist.Failure to heed this warning can result in dosage error.5. StorageAvoid direct sunlight and store at room temperature in a dry and clean place.6. CautionFederal law restricts this device to sale by or on the order of a physician.7. Expiry Date : 5 years from manufacturing date469-250-1748rikfedie@gmail.com
08800109007120DMject Insulin Syringe - 1. Insulin Syringe2. Intended use : For the injection of insulin and primarily in human.3. Instructions for use1) To expose plunger, remove large orange cap.2) To expose needle, pull small orange cap STRAIGHT off, being careful not to bend needle.3) To measure correct dosage align top edge of plunger tip with your dosage mark on the syringe scale.4) Use syringe ONCE only. To prevent misuse after injection, destroy syringe and needle.4. WarningFor patients who mix two types of insulin, do not change(a) the order of mixing that the physician has prescribed or(b) the model and brand of the syringe without first consulting your physician or pharmacist.Failure to heed this warning can result in dosage error.5. StorageAvoid direct sunlight and store at room temperature in a dry and clean place.6. CautionFederal law restricts this device to sale by or on the order of a physician.7. Expiry Date : 5 years from manufacturing date469-250-1748rikfedie@gmail.com
18800109007035DMject Insulin Syringe - 1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Instructions for use 1) To expose plunger, remove large orange cap. 2) To expose needle, pull small orange cap STRAIGHT off, being careful not to bend needle. 3) To measure correct dosage align top edge of plunger tip with your dosage mark on the syringe scale. 4) Use syringe ONCE only. To prevent misuse after injection, destroy syringe and needle. 4. Warning For patients who mix two types of insulin, do not change (a) the order of mixing that the physician has prescribed or (b) the model and brand of the syringe without first consulting your physician or pharmacist. Failure to heed this warning can result in dosage error. 5. Storage Avoid direct sunlight and store at room temperature in a dry and clean place. 6. Caution Federal law restricts this device to sale by or on the order of a physician. 7. Expiry Date : 5 years from manufacturing date469-250-1748rikfedie@gmail.com
18800109007127DMject Insulin Syringe - 1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Instructions for use 1) To expose plunger, remove large orange cap. 2) To expose needle, pull small orange cap STRAIGHT off, being careful not to bend needle. 3) To measure correct dosage align top edge of plunger tip with your dosage mark on the syringe scale. 4) Use syringe ONCE only. To prevent misuse after injection, destroy syringe and needle. 4. Warning For patients who mix two types of insulin, do not change (a) the order of mixing that the physician has prescribed or (b) the model and brand of the syringe without first consulting your physician or pharmacist. Failure to heed this warning can result in dosage error. 5. Storage Avoid direct sunlight and store at room temperature in a dry and clean place. 6. Caution Federal law restricts this device to sale by or on the order of a physician. 7. Expiry Date : 5 years from manufacturing date469-250-1748rikfedie@gmail.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
706961771062449K993017PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEFMF2000-02-25
706961849442683K071382SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,FOZ2007-10-16
706961814707390K070988SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)FMI2007-08-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FOZ22007-10-16
FMI22007-08-23
FMF22000-02-25

PMN#

GUDID#