FDA.reportPublic FDA data

Rongeur

Primary DI
00841668108482
Brand
Rongeur
Company
KATENA PRODUCTS, INC.
Model
K7-1801
Catalog number
K7-1801
Device description
KERRISON RONGEUR SIZE 1
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNGRongeur, lachrymal sac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNGRongeur, Lachrymal SacOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668108482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668108482008416681084828416681084820841668108482

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width3.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600info@katena.com
+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
04058935012762Belz Lacrimal Sac RongeurBausch & Lomb GmbHHNG2025-07-10
00757770404476Bausch + LombBausch & Lomb IncorporatedHNG2024-11-20
00850048576063Intacs Pocketing HookADDITION TECHNOLOGY, INC.HNG2023-06-13
00810799035554Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035561Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035578Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035585Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035592Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00841668108475RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108499RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108505RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108512RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108529RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00840159903339RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01
00840159907856RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01