FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 05414734400664
·
Model: 1191
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 05414734400664
- Version / Model
- 1191
- Catalog Number
- 1191
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-28
- Public Version
- 1
- Public Version Date
- 2018-04-02
- Public Version Status
- New
- Public Device Record Key
- f6bd1738-59a7-476a-bd70-0d767eae2082
Device Description
Tunneling Tool, 0.156"¿ Diameter
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HAO | INSTRUMENT, SURGICAL, NON-POWERED | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34827 | Tendon/ligament tunneller | A long, hand-held, manual surgical instrument designed to tunnel an artificial passageway along ligament and/or tendon tissue to create a connecting channel. It can have a variety of designs: 1) a long, round, stiff rod that tapers to a rounded point at the distal tip with a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue; or 2) a ring-handled instrument with long, slightly curved arms that join at a pivot point near the distal end, terminating in short grasping arms. It will typically be made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15414734400661 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 05414734400664 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store components and their packaging where they will not come in contact with liquids of any kind.
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 150 KiloPascal