FDA UDI
Not in Commercial Distribution
🇺🇸 United States
KEYPORT
DI: 04055207021071
·
Model: 8850243
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- KEYPORT
- Primary DI
- 04055207021071
- Version / Model
- 8850243
- Catalog Number
- 8850243
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 7
- Public Version Date
- 2023-05-26
- Public Version Status
- Update
- Public Device Record Key
- e88d787b-813d-4837-801e-22530acf765b
- Distribution End Date
- 2020-05-24
Device Description
SILICONE SEALING INSERT with three valve accesses, PACK=3 PCS, with connection for CO2 insufflation / smoke aspiration, reusable
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OTJ | Laparoscopic single port access device | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62452 | Laparoscopic multi-instrument access port, reusable | A multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207021071 | GS1 | ||||
| Unit of Use | 04055207059517 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]