FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ViaLume
DI: 00816908010672
·
Model: 7-45333
·
CYALUME TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ViaLume
- Primary DI
- 00816908010672
- Version / Model
- 7-45333
- Catalog Number
- 7-45333
- Company Name
- CYALUME TECHNOLOGIES, INC.
- Labeler DUNS
- 154779748
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-05
- Public Version
- 3
- Public Version Date
- 2020-03-03
- Public Version Status
- Update
- Public Device Record Key
- 7ca0f01a-c7b2-48b1-a966-9d4e6a14c1f6
- Distribution End Date
- 2020-03-02
Device Description
Self Illuminated Vaginal Speculum (Large, Screw Closure)
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37468 | Vaginal speculum, single-use | A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20816908010676 | GS1 | Case | 4 | Not in Commercial Distribution | 2020-03-02 |
| Package | 10816908010679 | GS1 | Inner Pack | 25 | Not in Commercial Distribution | 2020-03-02 |
| Primary | 00816908010672 | GS1 |
Customer Contacts
- Phone
- 1-888-733-4034
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 90 Degrees Fahrenheit