FDA UDI
In Commercial Distribution
🇺🇸 United States
PediGuard DSG Connect
DI: 03662674000488
·
Model: PediGuard DSG Connect Ø3.2
·
SPINEGUARD
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PediGuard DSG Connect
- Primary DI
- 03662674000488
- Version / Model
- PediGuard DSG Connect Ø3.2
- Catalog Number
- P1-AU512
- Company Name
- SPINEGUARD
- Labeler DUNS
- 260589566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-28
- Public Version
- 1
- Public Version Date
- 2025-09-05
- Public Version Status
- New
- Public Device Record Key
- 8e81e097-e65e-43f0-9076-25d156c5316d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | 874.1820 | 2 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | 882.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66274 | Bone awl, single-use | A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662674000488 | GS1 |
Customer Contacts
- Phone
- +33145184519
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201454 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.2 | Millimeter | |
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius