FDA UDI
In Commercial Distribution
🇺🇸 United States
PEDIGUARD THREADED
DI: 03662674000372
·
Model: STARTER Pin 1
·
SPINEGUARD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PEDIGUARD THREADED
- Primary DI
- 03662674000372
- Version / Model
- STARTER Pin 1
- Catalog Number
- D1SP0001
- Company Name
- SPINEGUARD
- Labeler DUNS
- 260589566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-26
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- bef40c32-fbf3-47e0-a9ee-8b4b0e85139c
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 |
|---|---|---|---|---|
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15275 | Bone awl, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662674000372 | GS1 |
Customer Contacts
- Phone
- +33145184519
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 308 | Millimeter | |
| Outer Diameter | 1.6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity