FDA UDI
In Commercial Distribution
🇺🇸 United States
Hurd tonsil suture needle, right, 22 cm
DI: 04250381887622
·
Model: 40-365-01
·
Spiggle & Theis Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hurd tonsil suture needle, right, 22 cm
- Primary DI
- 04250381887622
- Version / Model
- 40-365-01
- Catalog Number
- 40-365-01
- Company Name
- Spiggle & Theis Medizintechnik GmbH
- Labeler DUNS
- 332893028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-26
- Public Version
- 1
- Public Version Date
- 2022-10-04
- Public Version Status
- New
- Public Device Record Key
- 0b6fcf78-dc84-481d-9d74-120a405f0e04
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
- Yes
- 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 |
|---|---|---|---|---|
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32357 | Suturing needle, reusable | A non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. 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 | 04250381887622 | GS1 |
Customer Contacts
- Phone
- +492206908165
- [email protected]