Premier Edge® Microsurgical Knives
- Primary DI
- 00845819001813
- Brand
- Premier Edge® Microsurgical Knives
- Company
- OASIS MEDICAL, INC.
- Model
- PE3827, B-PE3827
- Device description
- Microsurgical Knife 2.75 mm Slit Knife
- Published
- 2023-04-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HNN | Knife, Ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HNN | Knife, Ophthalmic | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10845819001810 | Package | GS1 | 6 | In Commercial Distribution |
| 20845819001817 | Package | GS1 | 50 | In Commercial Distribution |
| 00845819001813 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10845819001810 | 10845819001810 | | |
| 20845819001817 | 20845819001817 | | |
| 00845819001813 | 00845819001813 | 845819001813 | 0845819001813 |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic knife, single-use | A sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Width | 2.75 | Millimeter |
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Regulatory Flags
- DUNS number
- 194121018
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00845819020111 | Surgeon's Choice Card | SCK 2011 | | 2024-11-07 |
| 10845819020118 | Surgeon's Choice Card | B-SCK 2011 | | 2024-11-07 |
| 10845819002916 | Premier Edge® Microsurgical Knives | PE3128-SL, B-PE3128-SL | | 2023-12-31 |
| 10845819002923 | Premier Edge® Microsurgical Knives | PE3818, B-PE3818 | | 2023-12-31 |
| 00845819002971 | Surgeon's Choice Card | SCK 2009, B-SCK 2009 | | 2023-12-27 |
| 10845819002985 | Surgeon's Choice Card | SCK 2009, B-SCK 2009 | | 2023-12-27 |
| 00845819002322 | Premier Edge® Microsurgical Knives | PE4827-TL, B-PE4827-TL | | 2023-04-30 |
| 00845819000267 | SOFT PLUG® Extended Duration Plugs | 6400V | | 2023-07-31 |
| 10845819000219 | SOFT PLUG® Extended Duration Plugs | 6402, 6402-A | | 2023-07-31 |
| 10845819005481 | SOFT PLUG® Extended Duration Plugs | 504 | | 2023-07-31 |
| 00845819000076 | Oasis REST & RELIEF Eye Mask | OM8000 | | 2023-06-30 |
| 10845819000080 | SOFT PLUG® Silicone Punctum Plug | 6610-S, 6610, 6610-D | | 2023-06-30 |
| 10845819000103 | SOFT PLUG® Silicone Punctum Plug | 6611-S, 6611, 6611-D | | 2023-06-30 |
| 00845819000120 | SOFT PLUG® Silicone Punctum Plug | 6612-S, 6612, 6612-D | | 2023-06-30 |
| 10845819000141 | SOFT PLUG® Silicone Punctum Plug | 6612-SFC, 6612-FC | | 2023-06-30 |
| 10845819000172 | SOFT PLUG® Silicone Punctum Plug | 6613-S, 6613, 6613-D | | 2023-06-30 |
| 10845819000202 | SOFT PLUG® Silicone Punctum Plug | 6614-S, 6614, 6614-D | | 2023-06-30 |
| 10845819000226 | SOFT PLUG® Silicone Punctum Plug | 6614-SFC, 6614-FC | | 2023-06-30 |
| 10845819000271 | FORM FIT® Hydrogel Canalicular Plug | 6303, 6303-T, B-6303 | | 2023-06-30 |
| 10845819000318 | Lacrimal lntubation Set | 6004 | | 2023-06-30 |
Other Devices Sharing Product Codes
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