FDA UDI
In Commercial Distribution
🇺🇸 United States
10ml Suresafe Syringe
DI: 05391530750660
·
Model: 10ml Syringe - 21G x 1 1/2"
·
DMC MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- 10ml Suresafe Syringe
- Primary DI
- 05391530750660
- Version / Model
- 10ml Syringe - 21G x 1 1/2"
- Catalog Number
- FD-SSIC10-21
- Company Name
- DMC MEDICAL LIMITED
- Labeler DUNS
- 989772017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- bedcde8d-7306-4dc9-9a4d-203990b7d835
Device Description
10ml Suresafe Automatic Retractable Syringe - 21G x 1 1/2" - Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45042 | Metered-delivery hypodermic syringe/needle | A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05391530750684 | GS1 | 8 | In Commercial Distribution | ||
| Package | 05391530750677 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 05391530750660 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143497 | 000 |