FDA UDI
In Commercial Distribution
🇺🇸 United States
BEAR
DI: G043624020
·
Model: 6.24.02
·
Bear-Ent, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BEAR
- Primary DI
- G043624020
- Version / Model
- 6.24.02
- Catalog Number
- 6.24.02
- Company Name
- Bear-Ent, LLC
- Labeler DUNS
- 123551586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-26
- Public Version
- 1
- Public Version Date
- 2023-02-03
- Public Version Status
- New
- Public Device Record Key
- 272c98d8-ad5e-4721-94fd-5602ba6d7c81
Device Description
McGee Crimping Forceps, Small
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | Ear, Nose, Throat | 874.3540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47510 | ENT wire crimper | A hand-held manual surgical instrument designed to bend wire directly in the cavities of the ears, nose, or throat. It is typically a straight or curved forceps-like instrument with a terminal end appropriately configured to manipulate wires in the cavities of the ears, nose, or throat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G043624020 | HIBCC |