Grafco
- Primary DI
- M36828031
- Brand
- Grafco
- Company
- GF HEALTH PRODUCTS, INC.
- Model
- 2803
- Catalog number
- 2803
- Device description
- NASAL SPECULUM VIENNA CHILD
- Published
- 2021-06-03
- 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
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KBE | Snare, Nasal | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| M36828031 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Nasal speculum, reusable | A hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device. |
Regulatory Flags
- DUNS number
- 132016168
- 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
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00842962149355 | HNM MEDICAL | HNM STAINLESS, LLC. | KBE | 2023-04-06 |
| 00842962149362 | HNM MEDICAL | HNM STAINLESS, LLC. | KBE | 2023-04-06 |
| 14026704808868 | PILLING | TELEFLEX INCORPORATED | KBE | 2022-12-08 |
| 54026704808873 | PILLING | TELEFLEX INCORPORATED | KBE | 2022-12-08 |
| 00842331177804 | Novo Surgical Inc. | NOVO SURGICAL, INC. | KBE | 2022-11-14 |
| 00887482042861 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBE | 2022-09-30 |
| G043799000 | BEAR | Bear-Ent, LLC | KBE | 2022-08-02 |
| G043799010 | BEAR | Bear-Ent, LLC | KBE | 2022-08-02 |
| 00190776048624 | Avalign | AVALIGN TECHNOLOGIES, INC. | KBE | 2021-11-03 |
| M36828051 | Grafco | GF HEALTH PRODUCTS, INC. | KBE | 2021-06-03 |
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| 00190660173616 | Ambler Surgical | AMBLER SURGICAL CORP. | KBE | 2021-01-04 |
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| 00190660173678 | Ambler Surgical | AMBLER SURGICAL CORP. | KBE | 2021-01-04 |
| 00190660173685 | Ambler Surgical | AMBLER SURGICAL CORP. | KBE | 2021-01-04 |
| 00190660173692 | Ambler Surgical | AMBLER SURGICAL CORP. | KBE | 2021-01-04 |
| 00190660173739 | Ambler Surgical | AMBLER SURGICAL CORP. | KBE | 2021-01-04 |
| 00190660173746 | Ambler Surgical | AMBLER SURGICAL CORP. | KBE | 2021-01-04 |
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