FDA UDI
In Commercial Distribution
🇺🇸 United States
Jenker
DI: D003A870131
·
Model: A87013
·
Dentsply Professional
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Jenker
- Primary DI
- D003A870131
- Version / Model
- A87013
- Catalog Number
- A87013
- Company Name
- Dentsply Professional
- Labeler DUNS
- 144140845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-26
- Public Version
- 1
- Public Version Date
- 2022-12-05
- Public Version Status
- New
- Public Device Record Key
- 79c97ce1-4b40-4323-9eb9-57f1e3facf0e
Device Description
Jenker Needle Recapper
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| DZM | NEEDLE, DENTAL | Dental | 872.4730 | 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 | D003A870131 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Read Instructions for Use
- Type
- Special Storage Condition, Specify
- Special Conditions
- Recapping step must be carried out one-handed to prevent the possibility of needle sticks.