FDA UDI
In Commercial Distribution
🇺🇸 United States
Doctors Choice
DI: G018SLL12525SN0
·
Model: SLL12525SN
·
Supply Line International Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Doctors Choice
- Primary DI
- G018SLL12525SN0
- Version / Model
- SLL12525SN
- Company Name
- Supply Line International Medical, LLC
- Labeler DUNS
- 079241502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-03
- Public Version
- 1
- Public Version Date
- 2021-02-11
- Public Version Status
- New
- Public Device Record Key
- e7d26829-6af8-48fd-8510-5d40eff61e6b
Device Description
Safety Syringe 1 ml LL, 25G x 1"
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
- No
- 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 |
|---|---|---|---|---|
| 36280 | Medication cartridge syringe, safety-needle | A sterile device consisting of a breech-loading metal barrel with plunger into which a hermetically-sealed glass cartridge containing medication is intended to fit. The device uses an attached protective recessed or shielded needle for hypodermic drug delivery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G018SLL12525SN0 | HIBCC | ||||
| Package | G018SLL12525SN1 | HIBCC | Box | 100 | In Commercial Distribution | |
| Package | G018SLL12525SN2 | HIBCC | Case | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190183 | 000 |