FDA UDI
In Commercial Distribution
🇺🇸 United States
ARROW
DI: 10801902198904
·
Model: IPN920876
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ARROW
- Primary DI
- 10801902198904
- Version / Model
- IPN920876
- Catalog Number
- AR-14703
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-10
- Public Version
- 2
- Public Version Date
- 2024-01-10
- Public Version Status
- Update
- Public Device Record Key
- ea402cc6-89b3-48d8-8d65-dc835f1c009c
Device Description
Pressure Transduction Probe for use with Arrow(R) Raulerson Spring-Wire Introduction Syringe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DQX | Wire, guide, catheter | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47568 | Suturing needle holder, single-use | A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30801902198908 | GS1 | Case | 2 | In Commercial Distribution | |
| Package | 20801902198901 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 10801902198904 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]