FDA UDI
In Commercial Distribution
🇺🇸 United States
TROCAR INTRODUCER FOR LTF 5MM SCOPE MAJ-1379
DI: 04953170452031
·
Model: MAJ-1379
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TROCAR INTRODUCER FOR LTF 5MM SCOPE MAJ-1379
- Primary DI
- 04953170452031
- Version / Model
- MAJ-1379
- Catalog Number
- N3831940
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-25
- Public Version
- 4
- Public Version Date
- 2023-01-16
- Public Version Status
- Update
- Public Device Record Key
- f680d7bd-ee39-4f33-b9e0-f17462720521
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 |
|---|---|---|---|---|
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Gastroenterology, Urology | 876.1500 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37142 | Endoscopic-access dilator, reusable | A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170452031 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]