Replacement backflush needle, straight 23G/0.6 mm for 1281.A/B backflush handpie
FDA UDIClass I (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Replacement backflush needle, straight 23G/0.6 mm for 1281.A/B backflush handpie FDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
- Device Name
- Replacement backflush needle, straight 23G / 0.6 mm for 1281.A/B backflush handpiece FDA UDI
- Model / Reference
- 1281.A5D23 FDA UDI
- Description
- Replacement backflush needle, straight 23G / 0.6 mm for 1281.A/B backflush handpiece FDA UDI
Identifiers
- Catalog Number
- 1281.A5D23 FDA UDI
- Primary DI / UDI-DI
- 08717872003528 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Vitrectomy fluid/gas handling handpiece/cannula
A comprehensive replacement backflush needle for ophthalmic surgical procedures, designed to safely and effectively handle vitreoretinal fluid and gas exchange. Utilizing a sharp 23G/0.6 mm straight cannula, this instrument is ideal for various techniques such as retinal fold manipulation, proliferative vitreoretinopathy (PVR) treatment, and simultaneous or sequential gas/fluid exchange.
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Also classified as Vitrectomy fluid/gas handling handpiece/cannula.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 5dfa1df4-2c76-42cf-ab1e-6a4edde2ea59 34 fields · synced Jul 19, 2026