FDA.reportPublic FDA data

Rumex

Primary DI
00840159903339
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
16-136
Catalog number
16-136
Device description
Kerrison Rounger, Size 0, 3.00 mm Wide, 9.00 mm Opening, Polished finish, Stainless Steel
Published
2020-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840159903339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159903339008401599033398401599033390840159903339

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.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
041546137
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840159900345Rumex18-30418-3042020-06-09
00840159900406Rumex18-30518-3052020-06-09
00840159900802Rumex18-30318-3032020-06-09
00840159903384Rumex18-30118-3012020-06-09
00840159903391Rumex18-301-118-301-12020-06-09
00840159903407Rumex18-30218-3022020-06-09
00840159903414Rumex18-30718-3072020-06-09
00840159903421Rumex18-30818-3082020-06-09
00840159903438Rumex18-31818-3182020-06-09
00840159905609Rumex18-30018-3002020-06-09
00840159907900Rumex18-300-118-300-12020-06-09
00840159907917Rumex18-303-118-303-12020-06-09
00840159907924Rumex18-305-118-305-12020-06-09
00840159907931Rumex18-31018-3102020-06-09
00840159907948Rumex18-31118-3112020-06-09
00840159907955Rumex18-31218-3122020-06-09
00840159907962Rumex18-31318-3132020-06-09
00840159907979Rumex18-31418-3142020-06-09
00840159902189Rumex9-011S9-011S2020-06-04
00840159902196Rumex9-012S9-012S2020-06-04

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
00841668108482RongeurKATENA 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
00840159907856RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01