FDA.reportPublic FDA data

Integra® Ruggles®-Redmond™

Primary DI
10381780490203
Brand
Integra® Ruggles®-Redmond™
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
0058LP
Catalog number
0058LP
Device description
LOANER Ultra-Coat® and Diamond™ Detach Kerrison Rongeurs 11" Kit
Published
2018-09-14
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
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780490203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178049020310381780490203

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

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
false
HCT/P
false
Kit
true
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800089Adler Instrument CompanyAdler, Inc.HAE2026-05-26
04057034294543Punch, acc. Kerrison, K-Rex™ 40° upwards 18cm 1mm,w.ejectorGeister Medizintechnik GmbHHAE2026-05-26
04058749092523NAFehling Instruments GmbH & Co. KGHAE2026-03-05
00190776416515MillenniumAvalign Technologies, Inc.HAE2026-02-16
00887482023389SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023396SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023402SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156186SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156223SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
20887482023376SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
04058749089776NAFehling Instruments GmbH & Co. KGHAE2025-09-01
04046955741212AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741229AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741236AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741243AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741250AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741267AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741274AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741281AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741298AESCULAPAESCULAP, INC.HAE2025-08-17
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04046955741311AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741328AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741335AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741342AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741359AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741366AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741373AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741380AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741397AESCULAPAESCULAP, INC.HAE2025-08-17