FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
M274RN62091
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
RN6209
Catalog number
RN6209
Device description
Rhoton Style Hook, 7-1/2", 1.9mm Hook, Style No. 9, Angled 90°, Semi-Sharp
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
10381780458975PrimaryGS10
M274RN62091SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178045897510381780458975

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct) to allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle90degree
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
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
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
04250418753395Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753180Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753197Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753203Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753210Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753227Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753234Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753241Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
10381780194354Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194361Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02