FDA UDI
In Commercial Distribution
🇺🇸 United States
Hayden Medical
DI: 00840319741337
·
Model: 190-217
·
Hayden Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hayden Medical
- Primary DI
- 00840319741337
- Version / Model
- 190-217
- Catalog Number
- 190-217
- Company Name
- Hayden Medical, Inc.
- Labeler DUNS
- 618214410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-14
- Public Version
- 1
- Public Version Date
- 2023-03-22
- Public Version Status
- New
- Public Device Record Key
- 00ffd042-569a-4dfa-b50d-0045c05c6a1d
Device Description
House Strut Pick, malleable medium shaft, angled 90°, 0.5 mm tip, 6-1/2" (16.5 cm)
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 |
|---|---|---|---|---|
| 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 | 00840319741337 | GS1 |
Customer Contacts
- Phone
- +1(661)296-7200
- [email protected]