FDA.reportPublic FDA data

Oph.Forceps

Primary DI
00841668118146
Brand
Oph.Forceps
Company
KATENA PRODUCTS, INC.
Model
08-01705
Catalog number
08-01705
Device description
Berke Ptosis Fcps, 27mm blades, w/lock
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOBClamp, muscle, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOBClamp, Muscle, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668118146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668118146008416681181468416681181460841668118146

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length27Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
085668598
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770406036Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770409952Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770420872Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770522712Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00194613007645MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613007652MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613018467MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613039769MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613095048MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613103705MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613104283MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613007669MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613034313MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613112691MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613043988MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2024-08-15
00194613053826MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2024-08-15
00190776357634MillenniumAvalign Technologies, Inc.HOB2023-11-17
00190776351946MILLENNIUMAvalign Technologies, Inc.HOB2023-09-28
00190776358976MILLENNIUMAvalign Technologies, Inc.HOB2023-09-28
G2239661010Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOB2023-09-28
00841668118139Oph.ForcepsKATENA PRODUCTS, INC.HOB2022-11-16
00190776076115AvalignAvalign Technologies, Inc.HOB2021-11-03
04049368069119N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069133N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069157N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069171N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069232N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069294N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069355N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069379N.A.Geuder AktiengesellschaftHOB2021-02-23