FDA UDI
In Commercial Distribution
🇺🇸 United States
V. Mueller
DI: 70885403111510
·
Model: M-1535
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- V. Mueller
- Primary DI
- 70885403111510
- Version / Model
- M-1535
- Catalog Number
- M-1535
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- cfc8fa06-4a16-405d-aa6f-70dc6252524e
Device Description
PIN SKULL ADULT DISPO SS 3/PK 12/BX
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 |
|---|---|---|---|---|
| HBL | HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) | Neurology | 882.4460 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46664 | Cervical spine immobilization head ring rod | An implantable, threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level. Commonly referred to as a pin, it is typically made of metal (e.g., stainless steel), may be ceramic-tipped, or made of non-ferromagnetic materials. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 70885403111510 | GS1 | ||||
| Unit of Use | 10885403111518 | GS1 | ||||
| Package | 20885403111515 | GS1 | Box | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]