FDA UDI
In Commercial Distribution
🇺🇸 United States
EYE SPECULA
DI: B974ESS0
·
Model: EYE SPECULA
·
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EYE SPECULA
- Primary DI
- B974ESS0
- Version / Model
- EYE SPECULA
- Catalog Number
- ESS
- Company Name
- DR.FRIGZ INTERNATIONAL(PVT)LTD,
- Labeler DUNS
- 645680125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-21
- Public Version
- 1
- Public Version Date
- 2022-11-29
- Public Version Status
- New
- Public Device Record Key
- f1e8ed38-628f-4fc1-9e37-a039f11cd568
Device Description
EYE SPECULA SOLID 15MM 1-1/2 INCH LENTH
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46959 | Eyelid speculum, single-use | A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B974ESS0 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.5 | Inch |