FDA.reportPublic FDA data

CAPTURE™

Primary DI
10381780242017
Brand
CAPTURE™
Company
Ascension Orthopedics, Inc.
Model
AI-6010
Catalog number
AI6010
Device description
CAPTURE™ High Torque Screw SystemThe cannula cleaning stylet is used to clean all cannulated instruments. This instrument is used with 2.5 and 3.0 mm instruments.
Published
2017-08-30
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
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
10381780242017PrimaryGS10
M269AI60101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178024201710381780242017

GMDN Terms#

Term, Definition table
TermDefinition
Intramedullary canal cleaning brush, reusableA hand-held manual surgical instrument designed to remove blood clots and bone debris from the intramedullary canal of a bone (marrow space) in preparation for the insertion of orthopaedic cement. It typically consists of a handle at the proximal end and bristles, fibres, or spines at the distal end which may be soft or stiff and are mounted along a single plane or radiate out around a central shaft which may be flexible or rigid. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
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