FDA.report

I/A Co-axial Handpiece Straight Tip

Primary DI
10848782023902
Brand
I/A Co-axial Handpiece Straight Tip
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
92-5000
Device description
I/A Co-axial Handpiece Straight Tip
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HMXCannula, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848782023902PackageGS15In Commercial Distribution
00848782023905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878202390210848782023902
00848782023905008487820239058487820239050848782023905

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags

DUNS number
812762226
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00848782051809OnatecOL456291OL4562912025-06-02
10848782051813OnatecON456291ON4562912025-06-02
10848782051820OnatecON245071ON2450712025-06-02
10848782051837OnatecON146571ON1465712025-06-02
10848782051844OnatecON244081ON2440812025-06-02
10848782051851OnatecON454081ON4540812025-06-02
00848782051861OnatecOL145091OL1450912025-06-02
00848782051878OnatecOL415591OL4155912025-06-02
00848782051892OnatecOL145081OL1450812025-06-02
00848782051908OnatecOL415681OL4156812025-06-02
10848782051912OnatecOE261391OE2613912025-06-02
10848782051929OnatecOE471691OE4716912025-06-02
10848782051936OnatecON456671ON4566712025-06-02
10848782051943OnatecOE481691OE4816912025-06-02
10848782051950OnatecOE341331OE3413312025-06-02
00848782051960OnatecOL494891OL4948912025-06-02
00848782051977OnatecOL415592OL4155922025-06-02

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