FDA.reportPublic FDA data

ProChondrix® Sizer Set

Primary DI
00081233702128
Brand
ProChondrix® Sizer Set
Company
DSM BIOMEDICAL, INC.
Model
58161-02
Device description
Single-use disposable orthopedic manual surgical instrument set
Published
2017-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081233702128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081233702128000812337021280812337021280081233702128

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131107757
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
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00812337020695Medeor Tendon Matrix30006-012026-03-24
00812337020701Medeor Tendon Matrix30006-022026-03-24
00812337020794Meso Tendon Matrix30054-012026-03-24
00812337020800Meso Tendon Matrix30054-022026-03-24
00812337020817Meso Tendon Matrix30054-032026-03-24
00812337020824Meso Tendon Matrix30054-042026-03-24
00812337020671Meso BioMatrix® Acellular Peritoneum Matrix 30063-079101622025-03-14
00812337020688Meso BioMatrix® Acellular Peritoneum Matrix 30063-089102202025-03-14
00812337020541Resolve Matrix™ Biologic Membrane30052-26RMAD222023-12-18
00812337020558Resolve Matrix™ Biologic Membrane30052-27RMAD242023-12-18
00812337020565Resolve Matrix™ Biologic Membrane30052-28RMAD452023-12-18
00812337020572Resolve Matrix™ Biologic Membrane30052-29RMAD682023-12-18
00812337020589Resolve Matrix™ Biologic Membrane30052-30RMAD232023-12-18
00812337020596Resolve Matrix™ Biologic Membrane30052-31RMAD342023-12-18
00812337020602xenoPATCH™30052-32XPM552023-12-12
M263W25000WizardBio Resorbable Calcium Phosphate Cement21004-05W250002019-01-02
00812337020442Drillable Bone Void Filler21005-0307.705.003S2023-01-11
00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
M26300110301005CopiOs® Bone Void Filler Sponge20101-0200-1103-010-052015-09-17

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Primary DI, Brand, Company table
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00190376700717IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
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00190776415723MillenniumAvalign Technologies, Inc.HXG2026-02-04
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03662663242233Alta ACDF SystemHighridge Medical, LLCHXG2025-12-18
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