FDA UDI
In Commercial Distribution
🇺🇸 United States
Susol® Probe Jobson-Horne 18cm (Pack of 25) Non Sterile
DI: 05060418837808
·
Model: SS21-2030M
·
BAILEY INSTRUMENTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Susol® Probe Jobson-Horne 18cm (Pack of 25) Non Sterile
- Primary DI
- 05060418837808
- Version / Model
- SS21-2030M
- Company Name
- BAILEY INSTRUMENTS LTD
- Labeler DUNS
- 769260357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-23
- Public Version
- 1
- Public Version Date
- 2024-01-31
- Public Version Status
- New
- Public Device Record Key
- e7de96d5-9071-4f28-b50f-88c074c20995
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAK | Probe, Ent | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63656 | Abdominal/ENT/orthopaedic surgical probe, single-use | A slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060418837792 | GS1 | Pack | 25 | In Commercial Distribution | |
| Primary | 05060418837808 | GS1 |