FDA UDI
In Commercial Distribution
🇺🇸 United States
Cannula for subcutaneous Implant/ pellet administration
DI: 04063574100008
·
Model: 10000
·
sfm medical devices GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cannula for subcutaneous Implant/ pellet administration
- Primary DI
- 04063574100008
- Version / Model
- 10000
- Company Name
- sfm medical devices GmbH
- Labeler DUNS
- 315549311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-23
- Public Version
- 1
- Public Version Date
- 2021-10-01
- Public Version Status
- New
- Public Device Record Key
- 1670c17a-8d5f-4aa3-865a-03984926c731
Device Description
Cannula for subcutaneous Implant/ pellet administration, 14 G x 50mm
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63148 | Pellet implantation cannula | A sterile, rigid tube intended for subcutaneous delivery of an implantable drug pellet. The cannula is typically designed with a proximal well/side-hole for pellet loading, and typically includes a trocar blade to assist cannula introduction and a push rod to drive the pellet down the cannula; the implant is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04063574100008 | GS1 |