FDA UDI
In Commercial Distribution
🇺🇸 United States
TYRX™
DI: 00643169983533
·
Model: NMRM6122
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TYRX™
- Primary DI
- 00643169983533
- Version / Model
- NMRM6122
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-16
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 77d3e695-423a-4c8e-a739-060ce1307819
Device Description
ENVELOPE NMRM6122 ABSORB MED US MKT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTL | Mesh, surgical, polymeric | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61126 | Implantable pulse generator mesh bag, bioabsorbable | An implantable woven/knitted or porous bag made from a bioabsorbable synthetic polymer(s) intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous pocket in which it is implanted. The device includes an antimicrobial coating intended to reduce the risk of infection. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169983533 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150291 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Envelope size: 2.5 in x 2.7 in (6.3 cm x 6.9 cm) |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius