FDA UDI
In Commercial Distribution
🇺🇸 United States
Anesthesia / Cytotomes
DI: 08175700149013
·
Model: AS13-1000-25g
·
AURORA SURGICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anesthesia / Cytotomes
- Primary DI
- 08175700149013
- Version / Model
- AS13-1000-25g
- Catalog Number
- AS13-1000-25g
- Company Name
- AURORA SURGICAL, LLC
- Labeler DUNS
- 968368832
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-10
- Public Version
- 1
- Public Version Date
- 2023-07-18
- Public Version Status
- New
- Public Device Record Key
- d479012f-4346-4c0e-bfe5-1da00d583867
Device Description
Retrobulbar Needle (Atkinson) 25g x 38mm
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
- No
- 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 |
|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62701 | Ophthalmic needle, reusable | A slender, straight hollow instrument, 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; it may also be intended for diagnostic 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08175700149013 | GS1 |