FDA.reportPublic FDA data

Ophthalmic Spatulas

Primary DI
00841668114322
Brand
Ophthalmic Spatulas
Company
KATENA PRODUCTS, INC.
Model
K20-3845
Catalog number
K20-3845
Device description
RUBENSTEIN CORNEAL ROLLER (BX/3)
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNDSpatula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668114322PrimaryGS10
00841668125380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668114322008416681143228416681143220841668114322
00841668125380008416681253808416681253800841668125380

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, single-useA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags#

DUNS number
085668598
Device count
3
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700483630240MORIAMORIA SAHND2026-09-25
00190776431464MillenniumAvalign Technologies, Inc.HND2026-09-22
00190776427801MillenniumAvalign Technologies, Inc.HND2026-08-26
00190776427924MillenniumAvalign Technologies, Inc.HND2026-08-26
B382S344933000Surgical DirectSurgical Direct, Inc.HND2026-07-31
B382S340861270Surgical DirectSurgical Direct, Inc.HND2026-07-29
G346EP400Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-23
00190776403836MillenniumAvalign Technologies, Inc.HND2026-07-21
00190776400385MillenniumAvalign Technologies, Inc.HND2026-07-17
G346EP175RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-06
00850083275983Intrace USAPILOTIS TECH LLCHND2026-07-03
G4533306290PEAK MEDICALPeak Medical Distribution Inc.HND2026-06-24
04251047903571Rowen Phaco Spatula & Bechert Nucleus RotatorA1 Medical GmbHHND2026-06-09
00757770688548Bausch + LombBausch & Lomb IncorporatedHND2026-05-11
00190776420994MillenniumAvalign Technologies, Inc.HND2026-04-30
00757770501229Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770505753Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511006Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511020Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511037Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511075Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770520138Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770522682Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
G346EP02SSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346P1607SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346EC34Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-20
G346EP1850Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-02
G346EP44900Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-01
00841668144398KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144404KatenaKATENA PRODUCTS, INC.HND2026-03-31