FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20613994518853
·
Model: 040618
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- NA
- Primary DI
- 20613994518853
- Version / Model
- 040618
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 7f756b6c-7545-44f5-8f19-e18f8a2121ab
Device Description
ACCESS 040618 ANTENNA TAPE PATCH GLOBAL
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
- 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
- No
- 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 |
|---|---|---|---|---|
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34831 | Hypoallergenic skin adhesive tape | A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20613994518853 | GS1 | ||||
| Unit of Use | 00613994518859 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P840001 | 020 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -34 – 57 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 135 Degrees Fahrenheit