FDA UDI
In Commercial Distribution
🇺🇸 United States
OFFICESPEC
DI: M648C0200010
·
Model: C020001
·
OBP CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- OFFICESPEC
- Primary DI
- M648C0200010
- Version / Model
- C020001
- Catalog Number
- C020001
- Company Name
- OBP CORPORATION
- Labeler DUNS
- 011560431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b40f2846-9384-4468-be15-b8ccd5857282
Device Description
SINGLE-SIDED VAGINAL SPECULUM WITH LIGHT SINGLE-USE SIZE MEDIUM
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
- 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 | M648C0200012 | HIBCC | CASE | 4 | In Commercial Distribution | |
| Package | M648C0200011 | HIBCC | BOX | 24 | In Commercial Distribution | |
| Primary | M648C0200010 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091937 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius