NA

Primary DI: 10603295080169
Brand: NA
Company: DEPUY ORTHOPAEDICS, INC.
Model: 2001-80-503
Catalog number: 200180503
Device description: CALCAR PLANER LARGE
Published: 2018-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

xx.xx

Product Codes

Code	Name
LYS	Bone mill

Product Code Classifications

Code	Device	Specialty	Class
LYS	Bone Mill	Orthopedic	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
10603295080169	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized
10603295080169	10603295080169

GMDN Terms

Term	Definition
Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Term

Definition

Bone-resection orthopaedic reamer, reusable

An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

Phone	Email
+1(800)255-2500	xx@xx.xx

Regulatory Flags

DUNS number: 080506581
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: 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

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10603295562108	VELYS Hip Navigation	451580151	451580151	2026-03-24
10603295553625	ATTUNE	2999-67-032	299967032	2026-02-17
10603295553632	ATTUNE	2999-67-033	299967033	2026-02-17
10603295553649	ATTUNE	2999-67-034	299967034	2026-02-17
10603295553656	ATTUNE	2999-67-035	299967035	2026-02-17
10603295554974	EMPHASYS	2999-67-046	299967046	2026-02-04
10603295080121	AML EXCEL	2001-65-000	200165000	2018-06-15
10603295082408	DURALOC	2015-24-000	201524000	2018-09-24
10603295083382	SIGMA	2024-57-111	202457111	2018-09-24
10603295084075	SIGMA	2024-85-005	202485005	2018-09-24
10603295088042	GLOBAL FX	2128-01-022	212801022	2018-09-24
10603295090540	GLOBAL AP	2130-01-055	213001055	2018-09-24
10603295090687	GLOBAL AP	2130-04-000	213004000	2018-09-24
10603295094005	NA	2178-30-122	217830122	2018-09-24
10603295095651	LCS COMPLETION	2178-60-028	217860028	2018-09-24
10603295096184	NA	2178-63-124	217863124	2018-09-24
10603295096191	NA	2178-63-126	217863126	2018-09-24
10603295098935	PINNACLE	2217-50-004	221750004	2018-09-24
10603295098942	PINNACLE	2217-50-005	221750005	2018-09-24
10603295098959	PINNACLE	2217-50-006	221750006	2018-09-24

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08720254007816	Sterilization tray NBM	Spierings Orthopaedics B.V.	LYS	2023-06-20
08720254007823	Housing	Spierings Orthopaedics B.V.	LYS	2023-06-20
08720254007830	Push Block	Spierings Orthopaedics B.V.	LYS	2023-06-20
08720254007847	Handle	Spierings Orthopaedics B.V.	LYS	2023-06-20
08720254007854	Screw nut	Spierings Orthopaedics B.V.	LYS	2023-06-20
08720254007861	Milling Drum Extra Extra Extra Fine	Spierings Orthopaedics B.V.	LYS	2023-06-20