FDA.reportPublic FDA data

Symmetry Surgical ULTRA

Primary DI
00887482073896
Brand
Symmetry Surgical ULTRA
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
46-2900
Catalog number
46-2900
Device description
RACK STERILIZING HAKIE INSTRUMENTS
Published
2016-06-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092437000CODMAN STERILIZATION CONTAINERSCodman & Shurtleff, Inc.2010-03-25KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482073896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482073896008874820738968874820738960887482073896

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM 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
00887482060100Symmetry Locke23-027923-02792022-09-01
00887482039342Symmetry Kleinert-Kutz20-178820-17882022-08-30
00887482044100Symmetry Carroll20-177520-17752022-08-30
00887482000236Symmetry Surgical14-104314-10432022-08-25
00887482000298Symmetry Surgical14-104414-10442022-08-25
00887482040133Symmetry Surgical09-151309-15132022-08-25
00887482040140Symmetry Surgical09-151409-15142022-08-25
00887482053164Symmetry Surgical09-151209-15122022-08-25
00887482053171Symmetry Surgical09-151609-15162022-08-25
00887482053188Symmetry Surgical09-151809-15182022-08-25
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850001720830X-PACEXPANDING INNOVATIONS, INC.KCT2026-07-30
D7702752883INSTRUMENTS TRAY FORSWEDEN & MARTINA SPAKCT2026-07-27
D7702752893SURGICAL KITSWEDEN & MARTINA SPAKCT2026-07-27
10886705032266NAMedos International SàrlKCT2026-07-22
00190776400484MillenniumAvalign Technologies, Inc.KCT2026-07-21
00385640093323INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093484INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093491INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093507INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00385640093514INSTRUSAFESummit Medical, Inc.KCT2026-07-17
00763000830076Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-07-17
00653159014208CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014215CASE MEDICALCase Medical Inc.KCT2026-06-08
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00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13