FDA.reportPublic FDA data

Integra®

Primary DI
10381780080923
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3721008
Catalog number
3721008
Device description
"Integra® McGee Crimp/Wire Closure Forceps, 3-1/4"", 0.8mm x 4.5mm Jaws"
Published
2018-09-17
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
HYAFORCEPS, WIRE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780080923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008092310381780080923

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length4.5Millimeter
Length5Millimeter
Width0.8Millimeter

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
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

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Primary DI, Brand, Company table
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03760225714096In2BonesIN2BONESHYA2024-12-13
04250603748526LAZICPeter Lazic GmbHHYA2024-11-20
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03700569626877Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
03700569626884Newclip InstrumentsNEWCLIP TECHNICSHYA2024-11-08
04049197473248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
04049197473255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHYA2024-09-20
00840183516758BR Surgical, LLCBR Surgical, LLCHYA2024-06-03
00840180519301General InstrumentsALPHATEC SPINE, INC.HYA2023-09-22
07898506853717QuinelatoSchobell Industrial LtdaHYA2023-07-07
07898506848676QuinelatoSchobell Industrial LtdaHYA2023-07-05
07898506814312QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853601QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853618QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853625QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853649QuinelatoSchobell Industrial LtdaHYA2022-12-16
07898506853724QuinelatoSchobell Industrial LtdaHYA2022-12-16
07899798203310SchobellSchobell Industrial LtdaHYA2022-11-28
00840180508336General InstrumentsALPHATEC SPINE, INC.HYA2022-10-13
00887482055410Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HYA2022-08-25
00850027837642StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
00850027837659StabilICEACUTUS MEDICAL, INC.HYA2022-04-01
04250603736608LAZICPeter Lazic GmbHHYA2021-12-22
04250603739487LAZICPeter Lazic GmbHHYA2021-12-22
00850027837529StabilICEACUTUS MEDICAL, INC.HYA2021-10-28
04250603736103LAZICPeter Lazic GmbHHYA2021-07-02
04250603736110LAZICPeter Lazic GmbHHYA2021-07-02