FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ECO BALLOON URO
DI: 04048223058091
·
Model: 1285-70-11S
·
Pajunk GmbH Medizintechnologie
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- ECO BALLOON URO
- Primary DI
- 04048223058091
- Version / Model
- 1285-70-11S
- Catalog Number
- 1285-70-11S
- Company Name
- Pajunk GmbH Medizintechnologie
- Labeler DUNS
- 317654283
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-04-02
- Public Version
- 6
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- b630ae09-750d-41ed-aaa1-35b1f32bb02f
- Distribution End Date
- 2025-06-17
Device Description
1285-70-11S
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04048223020982 | GS1 | ||||
| Primary | 04048223058091 | GS1 | ||||
| Previous | 14048223020989 | GS1 |
Customer Contacts
- Phone
- +1 770-493-6832
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090631 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius