FDA.reportPublic FDA data

Integra®

Primary DI
10381780245247
Brand
Integra®
Company
Ascension Orthopedics, Inc.
Model
G107991B
Catalog number
G107991B
Device description
Surgical Instruments Slotted Mallet
Published
2017-08-30
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780245247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178024524710381780245247

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length8.7Inch
Width2.5Inch

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
942377524
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
true
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
M269IMP89000MT1Movement®IMP-890-00MTIMP-890-00MT2017-09-05
M269IMP89000PP1Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780355922Titan™IMP-0926-030-00AIMP-0926-030-00A2018-10-04
10381780355939Titan™IMP-0926-030-01AIMP-0926-030-01A2018-10-04
10381780355946Titan™IMP-0926-030-02AIMP-0926-030-02A2018-10-04
10381780355953Titan™IMP-0926-030-03AIMP-0926-030-03A2018-10-04
10381780355960Titan™IMH-0926-000IMH-0926-0002018-10-04
M268TIWEDGEINSTP1TiWedgeTMTIWEDGEINSTP2016-08-15
M269AW32051CAPTURE™AW-3205AW32052017-08-30
10381780123026CAPTURE™ High Torque Screw SystemCSS500000625WTCSS500000625WT2017-10-09
10381780123033CAPTURE™ High Torque Screw SystemCSS500000630WTCSS500000630WT2017-10-09
10381780123040CAPTURE™ High Torque Screw SystemCSS500000640WTCSS500000640WT2017-10-09
10381780123057CAPTURE™ High Torque Screw SystemCSS500000650WTCSS500000650WT2017-10-09
10381780123064CAPTURE™ High Torque Screw SystemCSS500000670WTCSS500000670WT2017-10-09
M26922286111Integra®222861122286112017-08-30
M26922378111Integra®223781122378112017-08-30
M269AI11031CAPTURE™AI-1103AI11032017-08-30
M269AI31011CAPTURE™AI-3101AI31012017-08-30
M269AI32011CAPTURE™AI-3201AI32012017-08-30
M269AI32021CAPTURE™AI-3202AI32022017-08-30

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