FDA UDI
In Commercial Distribution
🇺🇸 United States
Shielded single blade trocar,11mm, w.automatic edge cover
DI: EMAH13061110
·
Model: 13.061.11
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Shielded single blade trocar,11mm, w.automatic edge cover
- Primary DI
- EMAH13061110
- Version / Model
- 13.061.11
- Catalog Number
- 13.061.11
- Company Name
- mahe medical gmbh
- Labeler DUNS
- 342243334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8401c5e9-351b-4e24-a0c7-5eede250ebe0
Device Description
Shielded single blade trocar,11mm, w.automatic edge cover
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 61424 | Laparoscopic trocar blade, reusable | A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EMAH13061111 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EMAH13061110 | HIBCC |
Customer Contacts
- Phone
- +49(0)746592750
- [email protected]