FDA UDI
In Commercial Distribution
🇺🇸 United States
m-protect3
DI: 04262358420022
·
Model: 28/29
·
qtec CE-med GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- m-protect3
- Primary DI
- 04262358420022
- Version / Model
- 28/29
- Catalog Number
- MP0028/29-12
- Company Name
- qtec CE-med GmbH
- Labeler DUNS
- 344010844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-17
- Public Version
- 1
- Public Version Date
- 2023-07-25
- Public Version Status
- New
- Public Device Record Key
- 8ac673cc-4032-401b-ad1b-f9cc198d3783
Device Description
m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38821 | Endoscopic-access dilator, single-use | A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04262358420022 | GS1 |
Customer Contacts
- Phone
- +4945180850360
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | suitable for stapler size 28/29 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry, keep away from sunlight