FDA.report

Moria

Primary DI
10848782018656
Brand
Moria
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
CDM-1402
Catalog number
CDM-1402
Device description
15DEG RS BLAD-TIP 6PK
Published
2021-09-14
Public version status
New
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
HNNKnife, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848782018656PackageGS16In Commercial Distribution
00848782018659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878201865610848782018656
00848782018659008487820186598487820186590848782018659

GMDN Terms

TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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

Other Devices From This Company

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10848782051516QuillVLP-4160 2025-07-11
00848782051786OnatecOL144091OL1440912025-06-02
00848782051793OnatecOL415691OL4156912025-06-02
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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