American Medicals
- Primary DI
- B35688695050
- Brand
- American Medicals
- Company
- American Medicals
- Model
- 1
- Published
- 2022-09-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|
| B35688695050 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic surgical drape | A protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device. |
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
- false
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 |