FDA UDI
In Commercial Distribution
🇺🇸 United States
Guide Glide II® Guidewire Introducer Needle
DI: M661S01318275
·
Model: S01318-2.759LF
·
Spectra Medical Devices, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Guide Glide II® Guidewire Introducer Needle
- Primary DI
- M661S01318275
- Version / Model
- S01318-2.759LF
- Company Name
- Spectra Medical Devices, LLC
- Labeler DUNS
- 118301171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-13
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- 750613f7-e8df-4caa-bb4c-bc61f6a4368b
Device Description
Guide Glide II® Guidewire Introducer Needle One-Wall Style, Pink Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 18G (0.12 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.038 in. (0.96 mm)
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M661S01318275 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082580 | 000 |