FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00681490142656
·
Model: 6177
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00681490142656
- Version / Model
- 6177
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 6c308c9c-0ade-4569-a008-67de8c1d995d
Device Description
ACCESS 6177 10BX STERILE RF HEAD COVER
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
- 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 |
|---|---|---|---|---|
| OSR | Pacemaker/icd/crt non-implanted components | Unknown | 3 | |
| KRG | Programmer, pacemaker | Cardiovascular | 870.3700 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58968 | Instrument management bag | A flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10681490142653 | GS1 | PK | 10 | In Commercial Distribution | |
| Primary | 00681490142656 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890003 | 065 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 120.0 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 135 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- – 95 Percent (%) Relative Humidity