FDA UDI
In Commercial Distribution
🇺🇸 United States
CRW®
DI: 10381780167334
·
Model: DHRSL5
·
INTEGRA LIFESCIENCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- CRW®
- Primary DI
- 10381780167334
- Version / Model
- DHRSL5
- Catalog Number
- DHRSL5
- Company Name
- INTEGRA LIFESCIENCES CORPORATION
- Labeler DUNS
- 963856096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-04-14
- Public Version
- 4
- Public Version Date
- 2022-10-25
- Public Version Status
- Update
- Public Device Record Key
- 8d0eecfa-e234-4845-9a34-61470eb93beb
Device Description
Disposable Head Ring Screws, Long (5 Packs of 2)
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HAW | Neurological stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35361 | Stereotactic radiosurgical invasive head frame | A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M248DHRSL51 | HIBCC | ||||
| Primary | 10381780167334 | GS1 | ||||
| Unit of Use | 00381780167337 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]