FDA UDI
In Commercial Distribution
🇺🇸 United States
ASPIRATING SYRINGE C-W TYPE SS
DI: D928107145S0
·
Model: 10-7145-S
·
W.H. Holden, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ASPIRATING SYRINGE C-W TYPE SS
- Primary DI
- D928107145S0
- Version / Model
- 10-7145-S
- Company Name
- W.H. Holden, Inc.
- Labeler DUNS
- 183854322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 1
- Public Version Date
- 2024-12-26
- Public Version Status
- New
- Public Device Record Key
- 78ff6afa-343f-48fe-b688-fe010968f870
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35869 | Dental anaesthesia syringe, intraligamentary | A hand-held manual dental device designed for injecting an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D928107145S0 | HIBCC |