FDA UDI
In Commercial Distribution
🇺🇸 United States
EcoBalloon DIL-XL
DI: 14048223008659
·
Model: 1285-60-11
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- EcoBalloon DIL-XL
- Primary DI
- 14048223008659
- Version / Model
- 1285-60-11
- Catalog Number
- 1285-60-11
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-04-16
- Public Version
- 2
- Public Version Date
- 2021-03-16
- Public Version Status
- Update
- Public Device Record Key
- d1fe9603-ee20-4dfa-adf3-11ef1eb739e9
- Distribution End Date
- 2025-03-15
Device Description
EcoBalloon DIL-XL Unilateral dilatation balloon Ø 11mm for extraperitoneal surgery
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 45342 | Laparoscopic access cannula anchor, single-use | A small, sterile, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping/locking mechanism. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14048223008659 | GS1 | ||||
| Unit of Use | 04048223008652 | GS1 |
Customer Contacts
- Phone
- +1(888)972-5865
- [email protected]