FDA UDI
In Commercial Distribution
🇺🇸 United States
FiXcision
DI: EAMIFIX20010
·
Model: FIX2001
·
AMI Agency for Medical Innovations GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FiXcision
- Primary DI
- EAMIFIX20010
- Version / Model
- FIX2001
- Catalog Number
- FIX2001
- Company Name
- AMI Agency for Medical Innovations GmbH
- Labeler DUNS
- 303655286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-14
- Public Version
- 2
- Public Version Date
- 2019-04-12
- Public Version Status
- Update
- Public Device Record Key
- 8c09fdfc-9e6d-4255-ab1d-e5072a4d1faa
Device Description
FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 63141 | Anal fistula circular cutter | A sterile device intended for the circumferential resection of tissue to treat simple anal fistula. It includes a probe for initial exploration of the fistula, a guide with attachable base plate, and cylindrical cutting tool; the cutting tool is intended to be passed down the guide towards the base plate to remove diseased tissue and allow fistula healing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EAMIFIX20011 | HIBCC | 10 | In Commercial Distribution | ||
| Primary | EAMIFIX20010 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182664 | 000 |