FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07613327459524
·
Model: OZ 1509900
·
Berchtold Holding GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07613327459524
- Version / Model
- OZ 1509900
- Catalog Number
- OZ 1509900
- Company Name
- Berchtold Holding GmbH
- Labeler DUNS
- 316153824
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 2
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 90562d1c-f073-4374-93a2-bfbc50983c2b
Device Description
Adapter, specialist head section, Neuro. Keep Dry.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | SUPPORT, PATIENT POSITION | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58055 | Operating/examination/treatment table headrest, reusable | A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest available in various shapes and sizes and might include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327459524 | GS1 |