FDA UDI
In Commercial Distribution
🇺🇸 United States
Ace Medical Company
DI: 00840217908931
·
Model: AM-513-04
·
Ebner Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ace Medical Company
- Primary DI
- 00840217908931
- Version / Model
- AM-513-04
- Catalog Number
- AM-513-04
- Company Name
- Ebner Medical, LLC
- Labeler DUNS
- 106135367
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-22
- Public Version
- 3
- Public Version Date
- 2025-04-16
- Public Version Status
- Update
- Public Device Record Key
- a8e445db-7a1f-41db-87f6-59a2d22d8d7b
Device Description
Isabella 45° Bayonet Titanium Tumor Forceps TC Angled 25° Tips 1.4mm x 13mm
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 11775 | Open-surgery biopsy forceps, reusable | A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840217908931 | GS1 |
Customer Contacts
- Phone
- 800-822-0314
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 45.0 | degree | |
| Width | 0.5 | Millimeter | |
| Width | 13.0 | Millimeter | |
| Length | 193.0 | Millimeter |