FDA UDI
In Commercial Distribution
🇺🇸 United States
Set Inject
DI: 08699207503005
·
Model: 21IN-0303000002
·
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Set Inject
- Primary DI
- 08699207503005
- Version / Model
- 21IN-0303000002
- Company Name
- SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
- Labeler DUNS
- 565402538
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-26
- Public Version
- 2
- Public Version Date
- 2025-06-23
- Public Version Status
- Update
- Public Device Record Key
- 08eca32a-00fd-4fb5-baf4-938163a2f71f
Device Description
Syringe Luer Lock - Set Inject - 3ml 3 p
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35904 | Metered-delivery hypodermic syringe | A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08699207503005 | GS1 | ||||
| Package | 18699207503002 | GS1 | box | 100 | In Commercial Distribution | |
| Package | 28699207503009 | GS1 | shipper carton | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- +905376713797
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |