FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BEAR
DI: B351B656100
·
Model: 6.56.10
·
Mytamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BEAR
- Primary DI
- B351B656100
- Version / Model
- 6.56.10
- Catalog Number
- 6.56.10
- Company Name
- Mytamed, Inc.
- Labeler DUNS
- 015903922
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-05
- Public Version
- 2
- Public Version Date
- 2025-07-08
- Public Version Status
- Update
- Public Device Record Key
- 3affc789-463e-4a36-94ff-cbdd1370cf8c
- Distribution End Date
- 2024-12-31
Device Description
Rosen Ear Needle, Blunt Tip, Medium Curve
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
- 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 |
|---|---|---|---|---|
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13039 | Middle ear pick | A fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B351B656100 | HIBCC |