FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTA-GUARD
DI: 05713513000362
·
Model: 2222
·
Rønvig Dental Manufacturing A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CONTA-GUARD
- Primary DI
- 05713513000362
- Version / Model
- 2222
- Company Name
- Rønvig Dental Manufacturing A/S
- Labeler DUNS
- 307549241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 1
- Public Version Date
- 2022-10-06
- Public Version Status
- New
- Public Device Record Key
- e6947bb9-330c-4554-ade9-61a9f86f9a69
Device Description
A autoclavable Recapping Stand for one-handed handling of injection needles to avoid needle stick injuries.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BRW | Protector, Dental | Anesthesiology | 868.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37461 | Needle recapping device, reusable | A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713513000362 | GS1 |