FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Epix Inline Laparoscopic Grasper
DI: 00607915124533
·
Model: C4150
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Epix Inline Laparoscopic Grasper
- Primary DI
- 00607915124533
- Version / Model
- C4150
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-30
- Public Version
- 3
- Public Version Date
- 2020-02-10
- Public Version Status
- Update
- Public Device Record Key
- 68a302c4-dcd0-46ce-92b9-85cc88173e2e
- Distribution End Date
- 2016-08-30
Device Description
Disposable Grasper
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | 884.1720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63658 | Surgical soft-tissue manipulation forceps, alligator, single-use | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures, typically during ear/nose/throat (ENT) surgery; it is not intended for insertion through an endoscope, nor into the eye and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915124530 | GS1 | 10 | Not in Commercial Distribution | ||
| Primary | 00607915124533 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 38 | Centimeter |