SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
SHINCHANG MEDICAL CO., LTD.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9616157 | 3003169040 | SHINCHANG MEDICAL CO., LTD. | 1 | N | 2027-01-01 | 144, 1gongdan-ro 6-gil Gumi-si Gyeongbuk KR 39385 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08800109007038 | DMject 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 date | 469-250-1748 | rikfedie@gmail.com |
| 08800109007120 | DMject 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 date | 469-250-1748 | rikfedie@gmail.com |
| 18800109007035 | DMject 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 date | 469-250-1748 | rikfedie@gmail.com |
| 18800109007127 | DMject 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 date | 469-250-1748 | rikfedie@gmail.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 70696 | 1771062449 | K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE | FMF | 2000-02-25 |
| 70696 | 1849442683 | K071382 | SCM 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, | FOZ | 2007-10-16 |
| 70696 | 1814707390 | K070988 | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) | FMI | 2007-08-23 |
SHINCHANG MEDICAL CO., LTD.
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