FDA UDI
In Commercial Distribution
🇺🇸 United States
Orabloc - needle stick safety system
DI: 08051040583000
·
Model: 20200707
·
PIERREL SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orabloc - needle stick safety system
- Primary DI
- 08051040583000
- Version / Model
- 20200707
- Catalog Number
- 20200707
- Company Name
- PIERREL SPA
- Labeler DUNS
- 458463044
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 2
- Public Version Date
- 2023-06-23
- Public Version Status
- Update
- Public Device Record Key
- b4fed59d-8f88-489f-82bc-50b277d98bc4
Device Description
The Needlestick Safety system is designed for safely recapping needles. The device consists of a disk, filled with 100 micro rubber caps, suitable for recapping needles after utilisation, for a safe disposal.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36187 | Needle recapping device, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08051040583000 | GS1 |
Customer Contacts
- Phone
- +390823626111
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 100 capsules that fit a range of needle sizes |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place at +5°C(41°F) to +40°C(104°F)