FDA UDI
In Commercial Distribution
🇺🇸 United States
STERiJECT OPHTHALMIC NEEDLE™
DI: 04573545740077
·
Model: VHPC-29010E
·
TSK LABORATORY INTERNATIONAL JAPAN K.K.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- STERiJECT OPHTHALMIC NEEDLE™
- Primary DI
- 04573545740077
- Version / Model
- VHPC-29010E
- Company Name
- TSK LABORATORY INTERNATIONAL JAPAN K.K.
- Labeler DUNS
- 717605253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-14
- Public Version
- 1
- Public Version Date
- 2025-07-22
- Public Version Status
- New
- Public Device Record Key
- 9773956d-6672-4ccf-8f27-9771d85ed0f5
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QYM | Ophthalmic Needle | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47610 | Ophthalmic needle, single-use | A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04571603050076 | GS1 | Inner Box | 50 | In Commercial Distribution | |
| Primary | 04573545740077 | GS1 | ||||
| Package | 14571603050073 | GS1 | Carton | 4800 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242073 | 000 |