FDA.reportPublic FDA data

GAMMA

Primary DI
07613154570386
Brand
GAMMA
Company
Stryker GmbH
Model
1320-0125S
Catalog number
1320-0125S
Device description
Closed Tube Clip
Published
2020-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
07613154570386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613154570386076131545703867613154570386

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, single-useA sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use device.

Regulatory Flags#

DUNS number
481999654
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327405743T22351-4515S2351-4515S2021-06-24
07613327697209PANGEASIT0007195SIT00071952026-08-27
07613327414127PANGEA706408S706408S2023-06-13
07613327415582PANGEA706407S706407S2023-06-13
07613327416138PANGEA706406S706406S2023-06-13
07613327539585PANGEA706444S706444S2023-06-13
07613327541731PANGEA703551S703551S2023-06-13
07613327541748PANGEA703555S703555S2023-06-13
07613154969357VARIAX45-35015S45-35015S2020-09-24
04546540195913NA1806-0083S1806-0083S2020-04-07
04546540195937NA1806-0085S1806-0085S2020-04-07
04546540195951NA1806-0090S1806-0090S2020-04-07
04546540195975NA1806-0093S1806-0093S2020-04-07
07613154633326NA45-20011S45-20011S2018-09-24
07613154633432NA45-30011S45-30011S2018-09-24
07613154665891NA45-20001S45-20001S2018-09-24
07613154665907NA45-20004S45-20004S2018-09-24
07613154665914NA45-30001S45-30001S2018-09-24
07613154665921NA45-30004S45-30004S2018-09-24
07613327083286AXSOS705077S705077S2016-09-24

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Primary DI, Brand, Company table
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08809986489777LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
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00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
B7685216080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.LXH2026-10-06
00810228161731corraCarlsmed, Inc.LXH2026-10-05
00840493441641LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
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M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
10888857615694CHESAPEAKE® Stabilization SystemVB Spine LLCLXH2026-09-23