FDA.reportPublic FDA data

MANTIS

Primary DI
07613327266689
Brand
MANTIS
Company
Stryker Corporation
Model
48284010
Catalog number
48284010
Device description
FASCIA SCISSORS
Published
2019-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327266689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327266689076133272666897613327266689

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
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
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586N93065370Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G586N93065380Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G28435301ScrewdriverNeurovention LLCHAO2022-06-21
07613327262322XIAStryker CorporationHAO2019-11-21
07613327264432XIA 4.5Stryker CorporationHAO2019-11-21
07613327264951XIA 3Stryker CorporationHAO2019-11-21
07613327271447OASYSStryker CorporationHAO2019-11-21
07613327276176RADIUSStryker CorporationHAO2019-11-21
07613327263787RELIANCE LITeStryker CorporationHAO2019-11-20
07613327263923RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265897RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265910RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265934RELIANCE LITeStryker CorporationHAO2019-11-20
07613327266016RELIANCE LITeStryker CorporationHAO2019-11-20
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