FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Olympus
DI: 04042761008969
·
Model: A5829
·
OLYMPUS Winter & Ibe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 04042761008969
- Version / Model
- A5829
- Catalog Number
- A5829
- Company Name
- OLYMPUS Winter & Ibe GmbH
- Labeler DUNS
- 316957240
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2022-08-11
- Public Version Status
- Update
- Public Device Record Key
- 46298e6f-c229-451d-94e7-8bf1ab55fff6
- Distribution End Date
- 2020-04-01
Device Description
Trocar spike, 11 mm, triangular, long
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61424 | Laparoscopic trocar blade, reusable | A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04042761008969 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923982 | 000 |