FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
10381780127062
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
R1325
Catalog number
R1325
Device description
"Integra® Ruggles®-Redmond™ Lempert Rongeur, 6-1/4"", curved, 2.5mm Bite"
Published
2016-08-11
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
HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780127062PrimaryGS10
M274R13251SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012706210381780127062

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
Device Size Text, specify0

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
Lot or batch
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662674000525PediGuard DSG ConnectSPINEGUARDHBG2025-09-17
10381780127901Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127918Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780127925Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-17
10381780177357Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-16
10381780127956Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780127963Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128182Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128199Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780128205Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780136408Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780142928Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780156802Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-14
10381780126744Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126751Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126768Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126775Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126782Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126836Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126874Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126904Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780126911Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127048Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127055Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127079Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127086Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127093Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127109Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127116Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11
10381780127123Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBG2016-08-11