FDA UDI
In Commercial Distribution
🇺🇸 United States
Lid for sterilization basket
DI: G006DJ4586SPEC142
·
Model: DJ-4586-SPEC
·
EFER ENDOSCOPY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lid for sterilization basket
- Primary DI
- G006DJ4586SPEC142
- Version / Model
- DJ-4586-SPEC
- Company Name
- EFER ENDOSCOPY
- Labeler DUNS
- 286097451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-14
- Public Version
- 1
- Public Version Date
- 2023-11-22
- Public Version Status
- New
- Public Device Record Key
- 76a7b1a6-1eda-479c-b411-aa50ff351422
Device Description
Lid for basket DJ-4561-SPEC (External dimensions: 770 x 250 mm)
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15074 | Rigid optical bronchoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the trachea, primary bronchi, and upper regions of the lungs. It is inserted through the mouth during the procedure called bronchoscopy. The inserted portion has an internal lumen sufficiently large to permit free respiration of the patient. The anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to diagnose lung infections, pneumonia, lung cancer, and allows physicians to view the upper regions of the lungs and take biopsies and samples of secretions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G006DJ4586SPEC142 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854414 | 000 |