FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Olympus
DI: 04042761002943
·
Model: A2246
·
OLYMPUS Winter & Ibe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 04042761002943
- Version / Model
- A2246
- Catalog Number
- A2246
- 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
- 2022-08-04
- Public Version Status
- Update
- Public Device Record Key
- 8c34a257-692c-48b7-84bc-93bfe6909165
- Distribution End Date
- 2019-10-01
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
- 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 |
|---|---|---|---|---|
| KOB | Catheter, Suprapubic (And Accessories) | Gastroenterology, Urology | 876.5090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47440 | Suprapubic needle, reusable | A hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with bladder prolapse. The needle is typically made of a high-grade stainless steel rod (curved or malleable) with a pointed tip and an eye or notch at the distal end to help position the sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04042761002943 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904798 | 000 |