FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
10381780233190
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
RN8142
Catalog number
RN8142
Device description
Integra® Ruggles®-Redmond™ Jacobson Scissors, 7", 15.5mm Blade, Flat Handle, Straight
Published
2018-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10381780233190PrimaryGS10
M274RN81421SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178023319010381780233190

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical scissorsA hand-held manual surgical instrument designed to cut tissue (e.g., dura mater, neural soft-tissue) during neurosurgery. It comprises two hinged blades of micro design that cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11
10381780154501Integra® Ruggles®-Redmond™R2382R23822016-08-11
10381780154518Integra® Ruggles®-Redmond™R2384R23842016-08-11
10381780154525Integra® Ruggles®-Redmond™R2389R23892016-08-11
10381780154532Integra® Ruggles®-Redmond™R2396R23962016-08-11
10381780154549Integra® Ruggles®-Redmond™R2397R23972016-08-11

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Primary DI, Brand, Company table
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B382SD9025151020Surgical DirectSurgical Direct, Inc.GZX2026-10-15
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00190776436445MilleniumAvalign Technologies, Inc.GZX2026-10-08
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00724995275112V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275129V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
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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
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