FDA UDI
In Commercial Distribution
🇺🇸 United States
Standard obturator quick-lock f. resectoscope sheaths 24/26CH
DI: EMAH3604010QL0
·
Model: 36.040.10QL
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Standard obturator quick-lock f. resectoscope sheaths 24/26CH
- Primary DI
- EMAH3604010QL0
- Version / Model
- 36.040.10QL
- Catalog Number
- 36.040.10QL
- 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
- fba7cc14-0f60-4283-9ee2-3720cbc0dfe8
Device Description
Standard obturator quick-lock f. resectoscope sheaths 24/26CH
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| FDC | RESECTOSCOPE, WORKING ELEMENT | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35692 | Rigid endoscope obturator | An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EMAH3604010QL1 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EMAH3604010QL0 | HIBCC |
Customer Contacts
- Phone
- +49(0)746592750
- [email protected]