FDA.reportPublic FDA data

AVS ARIA

Primary DI
04546540684301
Brand
AVS ARIA
Company
Stryker Corporation
Model
48755003
Catalog number
48755003
Device description
PROBE DILATOR 3
Published
2016-09-24
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
true

Product Codes#

Code, Name table
CodeName
GXZELECTRODE, NEEDLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540684301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540684301045465406843014546540684301

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

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Primary DI, Brand, Company table
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08720791377656CadwellTechnomed Engineering B.V.GXZ2025-05-26
08720791377670CadwellTechnomed Engineering B.V.GXZ2025-05-26
00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
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10816312027652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10816312027669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
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10841019122409KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
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08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374600NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374624NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374648NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374662NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374686NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375720CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375744CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375768CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375782CadwellTechnomed Engineering B.V.GXZ2025-02-28
10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-02-26