FDA.report

Integra® Ruggles®-Redmond™

Primary DI
M274R63181
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
R6318
Device description
ACF (Anterior Cervical Fusion) Bone Graft Harvesting Forceps, 8-1/2", 9mm Wide
Published
2017-06-27
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

Related Records

Contact Domains

Product Codes

CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780224549PrimaryGS10
M274R63181SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178022454910381780224549

GMDN Terms

TermDefinition
Bone cutting forcepsA strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089664ELMED INCORPORATEDELMED INCORPORATEDHAO2026-03-17
00810220800010Adler Instrument CompanyAdler, Inc.HAO2026-03-17
00810220800034Adler Instrument CompanyAdler, Inc.HAO2026-03-17
04058749078770NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749082357NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749123500NAFehling Instruments GmbH & Co. KGHAO2026-03-05
00816589021608Mini-Bolt Accessory KitMONTERIS MEDICAL INCHAO2026-02-23
00810123209835Adler Instrument CompanyAdler, Inc.HAO2026-02-10
04058749068443NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749068481NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076110NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076349NAFehling Instruments GmbH & Co. KGHAO2026-01-28
00810123209750Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00810123209767Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00873263009321Visualase Anchor Bolt ToolsFHC, INC.HAO2025-12-12
00873263009345Visualase Anchor Bolt DriverFHC, INC.HAO2025-12-12
00873263009352Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009369Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009376Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009383Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009390Visualase Sterilization & Storage TrayFHC, INC.HAO2025-12-12
00873263009406Visualase Anchor Bolt Removal ToolFHC, INC.HAO2025-12-12
04058749001846NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749002010NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749068467NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069969NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069976NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749076059NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08