American Medicals
- Primary DI
- B35648115010
- Brand
- American Medicals
- Company
- American Medicals
- Model
- 1
- Published
- 2022-09-09
- 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 Codes
| Code | Name |
|---|
| MDM | Instrument, Manual, Surgical, General Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B35648115010 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental cheek retractor, professional, reusable | A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Microwave Radiation |
Regulatory Flags
- DUNS number
- 109909627
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 06438394002678 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394002685 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394002692 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394020382 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 06438394010956 | Activa Instrument | Bioretec Oy | MDM | 2026-03-23 |
| 00198506089619 | ELMED INCORPORATED | ELMED INCORPORATED | MDM | 2026-03-17 |
| 00888867519459 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867519473 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867519503 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867519510 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529755 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529793 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00888867529823 | Arthrex® | ARTHREX, INC. | MDM | 2026-03-16 |
| 00198506089510 | ELMED INCORPORATED | ELMED INCORPORATED | MDM | 2026-03-13 |
| 00810158219236 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219243 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219250 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219281 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219304 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219311 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219359 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219373 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-12 |
| 00810158219007 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219014 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219021 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219038 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219069 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219090 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219106 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |
| 00810158219137 | PRINCETON | Princeton Medical Group, Inc. | MDM | 2026-03-11 |