FDA UDI
In Commercial Distribution
🇺🇸 United States
Instraspec
DI: 05010058088689
·
Model: 8868
·
ROBINSON HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Instraspec
- Primary DI
- 05010058088689
- Version / Model
- 8868
- Catalog Number
- 8868
- Company Name
- ROBINSON HEALTHCARE LIMITED
- Labeler DUNS
- 237799775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-12
- Public Version
- 2
- Public Version Date
- 2026-02-12
- Public Version Status
- Update
- Public Device Record Key
- 2ed24380-d6d5-4e54-bca5-fe9e7535ddc6
Device Description
Instraspec Contour Vaginal Speculum Extra Small x 25
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 05010058188686 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 05010058088689 | GS1 |
Customer Contacts
- Phone
- +441909735502
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and keep out of sunlight