FDA UDI
In Commercial Distribution
🇺🇸 United States
SLM
DI: 10816633020783
·
Model: SIC-45F-35R
·
SUNLIGHT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SLM
- Primary DI
- 10816633020783
- Version / Model
- SIC-45F-35R
- Company Name
- SUNLIGHT MEDICAL, INC.
- Labeler DUNS
- 039709088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-27
- Public Version
- 1
- Public Version Date
- 2024-04-04
- Public Version Status
- New
- Public Device Record Key
- 08a8ce24-0b6e-4a1b-b85d-cbf670d6d1ca
Device Description
ICSI Injection Pipette
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
- 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 |
|---|---|---|---|---|
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | Obstetrics/Gynecology | 884.6130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38522 | Mechanical pipette | A manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single channel or multichannel piston/cylinder pick-up assembly. The device transfers consistent volumes of liquid into one or several receptacles simultaneously (e.g., the wells of a microtitre plate). A pipette may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. The delivered volume may be mechanically indicated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30816633020787 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10816633020783 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072600 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry, Keep away from sunlight, Store at room temperature