FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BREMER
DI: 10705034243719
·
Model: AC007
·
DEPUY SPINE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BREMER
- Primary DI
- 10705034243719
- Version / Model
- AC007
- Catalog Number
- AC007
- Company Name
- DEPUY SPINE, LLC
- Labeler DUNS
- 107105876
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 5
- Public Version Date
- 2018-07-31
- Public Version Status
- Update
- Public Device Record Key
- aeffe71c-ca9d-46ab-9f40-8ff2231d9a07
- Distribution End Date
- 2018-07-31
Device Description
BREMER PEDIATRIC HALO SYSTEM SKULL PIN
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 |
|---|---|---|---|---|
| JEC | COMPONENT, TRACTION, INVASIVE | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60367 | Cervical spine immobilization system, single-use | An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705034243719 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915800 | 000 |