FDA UDI
In Commercial Distribution
🇺🇸 United States
Carnegie Surgical LLC
DI: G14157218660
·
Model: 572-1866
·
Carnegie Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carnegie Surgical LLC
- Primary DI
- G14157218660
- Version / Model
- 572-1866
- Catalog Number
- 572-1866
- Company Name
- Carnegie Surgical LLC
- Labeler DUNS
- 017636482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-17
- Public Version
- 1
- Public Version Date
- 2023-02-27
- Public Version Status
- New
- Public Device Record Key
- 5109864e-57b1-4d6d-b79d-769f0ee2be30
Device Description
LOCKWOOD abdominal demarcator, 9.5mm, with angled hinge, 12 3/4" (32.5 cm), without ratchet
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62468 | Surgical soft-tissue manipulation forceps, scissors-like, reusable | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G14157218660 | HIBCC |
Customer Contacts
- Phone
- (609) 249-2695
- [email protected]