Sleds

Primary DI
00842188109096
Brand
Sleds
Company
Trimed, INC.
Model
OSN-70
Catalog number
OSN-70
Device description
Olecranon Sled, 70mm
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDLPIN, FIXATION, SMOOTH, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDLPin, Fixation, Smooth, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010545000TBWTri-Med, Inc.2001-06-06NDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188109096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188109096008421881090968421881090960842188109096

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
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
00842188131981CannCompScrew 2.0mm (SelfDrill)L2026L20262026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)L2028L20282026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)L2030L20302026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)L2032L20322026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)L2034L20342026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)L2036L20362026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)L2038L20382026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)L2040L20402026-06-02
00842188121678CannCompScrew 1.7mm (SelfDrill)L1707L17072021-01-11
00842188121685CannCompScrew 2.3mm (SelfDrill)L2311L23112021-01-11
00842188121692CannCompScrew 2.3mm (SelfDrill)L2313L23132021-01-11
00842188121708CannCompScrew 2.3mm (SelfDrill)L2315L23152021-01-11
00842188121715CannCompScrew 2.3mm (SelfDrill)L2317L23172021-01-11
00842188121722CannCompScrew 2.3mm (SelfDrill)L2319L23192021-01-11
00842188121746CannCompScrew 3.0mm (SelfDrill)L3011L30112021-01-11
00842188121753CannCompScrew 3.0mm (SelfDrill)L3013L30132021-01-11
00842188121760CannCompScrew 3.0mm (SelfDrill)L3015L30152021-01-11
00842188121777CannCompScrew 3.0mm (SelfDrill)L3017L30172021-01-11
00842188121784CannCompScrew 3.0mm (SelfDrill)L3019L30192021-01-11
00842188121791CannCompScrew 3.0mm (SelfDrill)L3027L30272021-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132575SledsTrimed, INC.NDL2026-07-24
00842188132582SledsTrimed, INC.NDL2026-07-24
00842188131158SledsTrimed, INC.NDL2026-02-19
00842188131165SledsTrimed, INC.NDL2026-02-19
00842188129759K-wiresTrimed, INC.NDL2025-04-23
00842188128233WireformsTrimed, INC.NDL2025-02-12
00842188128240WireformsTrimed, INC.NDL2025-02-12
00842188128257WireformsTrimed, INC.NDL2025-02-12
00842188128264WireformsTrimed, INC.NDL2025-02-12
00842188128271WireformsTrimed, INC.NDL2025-02-12
00842188128288WireformsTrimed, INC.NDL2025-02-12
00842188128295WireformsTrimed, INC.NDL2025-02-12
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00842188109065SledsTrimed, INC.NDL2016-09-07
00842188109072SledsTrimed, INC.NDL2016-09-07
00842188109089SledsTrimed, INC.NDL2016-09-07
00842188109102WireformsTrimed, INC.NDL2016-09-07
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00842188109126WireformsTrimed, INC.NDL2016-09-07
00842188109133WireformsTrimed, INC.NDL2016-09-07
00842188109140WireformsTrimed, INC.NDL2016-09-07
00842188109157WireformsTrimed, INC.NDL2016-09-07
00842188109164WireformsTrimed, INC.NDL2016-09-07
00842188109171WireformsTrimed, INC.NDL2016-09-07
00842188109188WireformsTrimed, INC.NDL2016-09-07