FDA UDI
In Commercial Distribution
🇺🇸 United States
AccuTip Cover
DI: 00897826002116
·
Model: AX11286
·
ACCUTOME, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
600
Basic Information
- Brand Name
- AccuTip Cover
- Primary DI
- 00897826002116
- Version / Model
- AX11286
- Catalog Number
- AX11286
- Company Name
- ACCUTOME, INC.
- Labeler DUNS
- 048792816
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 600
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 4
- Public Version Date
- 2021-11-29
- Public Version Status
- Update
- Public Device Record Key
- 6969b222-1807-4f7c-864a-bdaae28ea3ed
Device Description
Bulk, non-sleeved
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HKY | Tonometer, Manual | Ophthalmic | 886.1930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45750 | Ophthalmic tonometer tip cover | A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00897826002116 | GS1 | ||||
| Unit of Use | 00897826002130 | GS1 |