FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
10381780225737
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
R8888
Catalog number
R8888
Device description
"Integra® Ruggles®-Redmond™ Fukushima-Chen Tumor Knife, 7-1/2"", Round, 1.5mm Tip, Bayonet, Angled, Sharp"
Published
2018-03-01
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
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780225737PrimaryGS10
M274R88881SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178022573710381780225737

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length1.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02
10381780519195CODMAN® HAKIM®82311682-31162020-06-02
10381780519249CODMAN® HAKIM®82316482-31642020-06-02
10381780519256CODMAN® HAKIM®82318282-31822020-06-02
10381780519263CODMAN® HAKIM®82318482-31842020-06-02
10381780519447CODMAN® HAKIM®82328182-32812020-06-02
10381780519478CODMAN® HAKIM®82328482-32842020-06-02
10381780519485CODMAN® HAKIM®82328582-32852020-06-02
10381780519751CODMAN® HAKIM®82382182-38212020-06-02
10381780519768CODMAN® HAKIM®82382282-38222020-06-02
10381780519799CODMAN® HAKIM®82382582-38252020-06-02
10381780519805CODMAN® HAKIM®82383282-38322020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437800MillenniumAvalign Technologies, Inc.GZX2026-10-20
B382SD9025151020Surgical DirectSurgical Direct, Inc.GZX2026-10-15
04058749013375NAFehling Instruments GmbH & Co. KGGZX2026-10-12
04058749013818NAFehling Instruments GmbH & Co. KGGZX2026-10-12
00190776436445MilleniumAvalign Technologies, Inc.GZX2026-10-08
00724995275082V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275099V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275105V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275112V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275129V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293581V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293598V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293604V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293611V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306281V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306298V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306304V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00190776424121MillenniumAvalign Technologies, Inc.GZX2026-08-27
00190776420376MillenniumAvalign Technologies, Inc.GZX2026-08-25
00190776419134MillenniumAvalign Technologies, Inc.GZX2026-08-23
00190776427191MillenniumAvalign Technologies, Inc.GZX2026-08-21
00190776414672MillenniumAvalign Technologies, Inc.GZX2026-08-18
00190776408640MillenniumAvalign Technologies, Inc.GZX2026-08-03
00190776407407MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407414MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776422271MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407322MillenniumAvalign Technologies, Inc.GZX2026-07-28
00190776404093MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404116MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24