Guide Glide II® Guidewire Introducer Needle
- Primary DI
- M661S01321275
- Brand
- Guide Glide II® Guidewire Introducer Needle
- Company
- Spectra Medical Devices, LLC
- Model
- S01321-2.759LF
- Device description
- Guide Glide II® Guidewire Introducer Needle One-Wall Style, Green Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 21G (0.08 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.021 in. (0.53 mm)
- Published
- 2023-10-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| DYB | Introducer, Catheter |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| M661S01321275 | Primary | HIBCC | 0 | |
Regulatory Flags#
- DUNS number
- 118301171
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| M661S013182759 | Guidewire Introducer Needle | S013182759L | | 2024-06-18 |
| M661S010212753 | Guide Glide II® Guidewire Introducer Needle | S01021-2.753L | | 2024-02-12 |
| M661S01318275 | Guide Glide II® Guidewire Introducer Needle | S01318-2.759LF | | 2023-10-13 |
| M661S103417350 | Plastic BD Style Hub Tuohy Epidural Needle | S103417-3.50NL | | 2024-06-18 |
| M661S103418350 | Plastic BD Style Hub Tuohy Epidural Needle | S103418-3.50LT | | 2024-06-18 |
| M661S103418500 | Plastic BD Style Hub Tuohy Epidural Needle | S10341-8.500LT | | 2024-06-18 |
| M661S80C21600 | MSK Ultrasonic Injection Needle | S80C21-6.00BLX | | 2024-06-18 |
| M661S80C22200 | MSK Ultrasonic Injection Needle | S80C22-2.00BLX | | 2024-06-18 |
| M661S80C23200 | MSK Ultrasonic Injection Needle | S80C23-2.00BL | | 2024-06-18 |
| M661S90C22600 | MSK Ultrasonic Injection Needle | S90C22-6.00BLX | | 2024-06-18 |
| M661S80C21200 | MSK Ultrasonic Injection Needle | S80C21-2.00BLX | | 2024-02-12 |
| M661S80C21400 | MSK Ultrasonic Injection Needle | S80C21-4.00BLX | | 2024-02-12 |
| M661SST221505 | Radiofrequency (RF) Needle | SST221505SL | | 2024-06-18 |
| M661S075173501 | Plastic Standard Hub Tuohy Epidural Needle | S07517-3.501B | | 2024-06-18 |
| M661S075175001 | Plastic Standard Hub Tuohy Epidural Needle | S07517-5.001B | | 2024-06-18 |
| M661S075183501 | Plastic Standard Hub Tuohy Epidural Needle | S07518-3.501B | | 2024-06-18 |
| M661S075185001 | Plastic Standard Hub Tuohy Epidural Needle | S07518-5.001B | | 2024-06-18 |
| M661S135143508 | Metal Standard Hub Tuohy Epidural Needle | S13514-3.508C | | 2024-06-18 |
| M661S135144008 | Metal Standard Hub Tuohy Epidural Needle | S13514-4.008C | | 2024-06-18 |
| M661S135173008 | Metal Standard Hub Tuohy Epidural Needle | S13517-3.008B | | 2024-06-18 |
Other Devices Sharing Product Codes#