FDA UDI
In Commercial Distribution
🇺🇸 United States
Pinpoint GT
DI: 00801741128912
·
Model: 9770646
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Pinpoint GT
- Primary DI
- 00801741128912
- Version / Model
- 9770646
- Catalog Number
- 9770646
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b281ff9c-1e74-4eeb-8c1e-6c6d1f852d50
Device Description
Pinpoint GT Needle
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61547 | Peripheral nerve-block sharp needle | A sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741128919 | GS1 | CA | 20 | In Commercial Distribution | |
| Primary | 00801741128912 | GS1 | ||||
| Package | 30801741128913 | GS1 | BX | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 24 | Gauge | |
| Length | 1.5 | Inch |