FDA UDI
In Commercial Distribution
🇺🇸 United States
MindsEye Expandable Port
DI: 18600034768199
·
Model: 6.2cm
·
Minnetronix Neuro, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MindsEye Expandable Port
- Primary DI
- 18600034768199
- Version / Model
- 6.2cm
- Catalog Number
- N-EXP1A-062
- Company Name
- Minnetronix Neuro, Inc.
- Labeler DUNS
- 117223608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-18
- Public Version
- 3
- Public Version Date
- 2022-09-26
- Public Version Status
- Update
- Public Device Record Key
- ff4274a0-94eb-4dcb-9ba0-76ba35d33d61
Device Description
subcortical access sheath 6.2 cm
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
- No
- 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 |
|---|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | 882.4800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62990 | Neurosurgical retraction cannula | A single-lumen surgical device designed to be used with an obturator to atraumatically displace brain tissues without tissue penetration (e.g., careful insertion between gyri) to create a surgical access corridor to a specific lesion/abnormality within the brain; a disposable obturator may be included. It is made of polymer materials and may include depth markings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18600034768199 | GS1 |
Customer Contacts
- Phone
- 1-833-372-1194
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202072 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.2 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius