FDA UDI
In Commercial Distribution
🇺🇸 United States
Precautions of Using the Sterilization Cap
DI: 04953170233012
·
Model: MAJ-1538
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Precautions of Using the Sterilization Cap
- Primary DI
- 04953170233012
- Version / Model
- MAJ-1538
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 11
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 25991214-ef11-4aef-87ef-155e7f011ee2
Device Description
MAJ-1538 Sterilization Cap
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4760 | 2 |
| NWB | Endoscope, accessories, narrow band spectrum | Gastroenterology, Urology | 876.1500 | 2 |
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61723 | Luminal device flushing tubing set, reusable | A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170233012 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]