DEVICE: Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm (08717872016085)

Device Identifier (DI) Information

Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm
1281.BD27
In Commercial Distribution
1281.BD27
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
08717872016085
GS1

10
407522184 *Terms of Use
Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm for use with classic DORC backflush handpiece.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47130 Vitrectomy fluid/gas handling handpiece/cannula
A sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
HMX Cannula, Ophthalmic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7c9d7564-f1df-4a87-be11-0901dae2e3a8
February 22, 2021
2
February 02, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 18717872016082 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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