FDA UDI
In Commercial Distribution
🇺🇸 United States
ADEPT MEDICAL
DI: M6333814351
·
Model: 38-1435
·
JEDMED INSTRUMENT COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- ADEPT MEDICAL
- Primary DI
- M6333814351
- Version / Model
- 38-1435
- Catalog Number
- 38-1435
- Company Name
- JEDMED INSTRUMENT COMPANY
- Labeler DUNS
- 092987189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 1
- Public Version Date
- 2020-09-09
- Public Version Status
- New
- Public Device Record Key
- 406106b9-168b-4c0b-ad68-237e53661a42
Device Description
JOBSON HORNE PROBES OVAL PK/100
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 33433 | ENT probe, reusable | A slender, rod-like, hand-held manual surgical instrument, typically with a blunt bulbous or pointed tip, used for exploring fistulas, cavities or wounds used during ear/nose/throat (ENT) intervention. The distal end of the instrument, before the bulb/point, may be bent at a right angle to the shaft. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | M633S3814350 | HIBCC | ||||
| Primary | M6333814351 | HIBCC |