FDA UDI
In Commercial Distribution
🇺🇸 United States
Boston Endo Surgical Technologies LLC
DI: 00853508002355
·
Model: PK1014
·
Lacey Manufacturing Company, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Boston Endo Surgical Technologies LLC
- Primary DI
- 00853508002355
- Version / Model
- PK1014
- Catalog Number
- PK1014
- Company Name
- Lacey Manufacturing Company, LLC
- Labeler DUNS
- 958212029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-05
- Public Version
- 2
- Public Version Date
- 2023-04-19
- Public Version Status
- Update
- Public Device Record Key
- c684c8d0-fc16-4fe2-8346-2a8ff80e28c6
Device Description
Pedicle Access Needle- NIM Pedicle Probe Lumbar
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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60478 | Bone access cannula | A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853508002355 | GS1 |
Customer Contacts
- Phone
- 203-336-7453
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.690 | Inch |