FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Devon
DI: 10884527015870
·
Model: 31160297
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- Devon
- Primary DI
- 10884527015870
- Version / Model
- 31160297
- Catalog Number
- 31160297
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 4
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- ee57f7f2-b8d9-46be-baaf-4f040b4c28b7
- Distribution End Date
- 2023-07-01
Device Description
Tube Holder
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| KGZ | ACCESSORIES, CATHETER | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61111 | Intracranial catheter holder | A small, sterile device designed to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may also be used as a marker for the planned depth of the catheter insertion. It typically has a gripping mechanism which creates a right angle bend in the tube, and is intended to be held in place with sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884527015870 | GS1 | ||||
| Unit of Use | 20884527015877 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;