EYE SPECULA
- Primary DI
- B974ES500P0
- Brand
- EYE SPECULA
- Company
- DR.FRIGZ INTERNATIONAL(PVT)LTD,
- Model
- EYE SPECULA HOLLOW
- Catalog number
- ES500P
- Device description
- EYE SPECULA HOLLOW 15MM 1-1/2 INCH LENTH
- Published
- 2022-11-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| HNC | Specula, Ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HNC | Specula, Ophthalmic | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B974ES500P0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 1.5 | Inch |
Regulatory Flags
- DUNS number
- 645680125
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
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|---|
| B974111310 | SCISSORS | TENOTOMY SCISSORS | 11131 | 2022-11-22 |
| B974111400 | Single Use Scissor | EPISIOTOMY SCISSORS | 11140 | 2022-11-22 |
| B974122000 | FORCEPS | PEAN FORCEPS | 12200 | 2022-11-22 |
| B974132420 | FORCEPS | LORNA TOWEL FORCEPS | 13242 | 2022-11-22 |
| B974132430 | FORCEPS | LORNA TOWEL FORCEPS | 13243 | 2022-11-22 |
| B9741629004 | NEEDLE HOLDER | MAYO HEGAR NEEDLE HOLDERS | 16290 | 2022-11-22 |
| B9742370 | FORCEPS | SPONGE FORCEPS | 237 | 2022-11-22 |
| B974256950 | EAR FORCEPS | JANSEN EAR FORCEPS | 25695 | 2022-11-22 |
| B9743290808 | NAIL NIPPERS | NAIL NIPPERS | 32908 | 2022-11-22 |
| B97450524507 | FORCEPS | Debakey Forceps | 505245 | 2022-11-22 |
| B9748112604 | OPERATING SCISSORS | CVD | 81126 | 2022-11-22 |
| B974813100 | SCISSORS | MAYO SCISSORS | 81310 | 2022-11-22 |
| B9748148007 | SCISSORS | STRABISMUS SCISSORS | 81480 | 2022-11-22 |
| B974814850 | SCISSORS | STRABISMUS SCISSORS | 81485 | 2022-11-22 |
| B974818900 | FORCEPS | PEAN FORCEPS | 81890 | 2022-11-22 |
| B974AF25720S0 | EAR FORCEPS | MICRO ALLIGATOR FORCEPS | AF25720S | 2022-11-22 |
| B974ATF8PAS0 | FORCEPS | ALLIS TISSUE FORCEPS | ATF8PAS | 2022-11-22 |
| B974BES6PAS0 | SCISSORS | EPISIOTOMY SCISSORS | BES6PAS | 2022-11-22 |
| B974BNH21906 | NEEDLE HOLDER | BAUMGARTNER NEEDLE HOLDER | BNH219 | 2022-11-22 |
| B974BTC17306 | TOWEL CLAMP | TOWEL CLAMP | BTC173 | 2022-11-22 |
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