FDA.reportPublic FDA data

NA

Primary DI
07613327057119
Brand
NA
Company
STRYKER CORPORATION
Model
0310034104
Catalog number
0310-034-104
Device description
Square Punch, 15 Degree Upshaft
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327057119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327057119076133270571197613327057119

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Premarket exempt
true
Lot or batch
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
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
EZPF85140000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142200HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85145000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85150000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85195650HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85312070HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85180000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180020HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09