FDA.reportPublic FDA data

REMA Shaver Blades

Primary DI
04059223166273
Brand
REMA Shaver Blades
Company
DEWIMED Medizintechnik GmbH
Model
15-60460
Catalog number
15-60460
Device description
ROUND BURR 4,2 Ø MM AUTOKLAVIERBAR
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXRSpatula, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059223166273PrimaryGS10
14035282341254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059223166273040592231662734059223166273
1403528234125414035282341254

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, reusableA cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
343472288
Device count
5
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
04059223159886REMA Shaver Blades15-6143015-614302025-02-27
04059223159893REMA Shaver Blades15-6158015-615802025-02-27
04059223160028REMA Shaver Blades15-6144015-614402025-02-27
04059223160035REMA Shaver Blades15-6151015-615102025-02-27
04059223160059REMA Shaver Blades15-6152015-615202025-02-27
04059223160073REMA Shaver Blades15-6153015-615302025-02-27
04059223160103REMA Shaver Blades15-6154015-615402025-02-27
04059223160127REMA Shaver Blades15-6156015-615602025-02-27
04059223160523REMA Shaver Blades15-6151515-615152025-02-27
04059223160899REMA Shaver Blades15-6143115-614312025-02-27
04059223160905REMA Shaver Blades15-6144115-614412025-02-27
04059223164873REMA Shaver Blades15-6221015-622102025-02-27
04059223166303REMA Shaver Blades15-6148015-614802025-02-27
14035282341599REMA Shaver Blades15-6143015-614302025-02-27
14035282341841REMA Shaver Blades15-6158015-615802025-02-27
14035282341636REMA Shaver Blades15-6144015-614402025-02-27
14035282341711REMA Shaver Blades15-6151015-615102025-02-27
14035282341766REMA Shaver Blades15-6152015-615202025-02-27
14035282341780REMA Shaver Blades15-6153015-615302025-02-27
14035282341803REMA Shaver Blades15-6154015-615402025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811146700INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
09348811146717INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
04059223157875REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223157899REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223157943REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223160837REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223160844REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223166280REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341216REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341230REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341278REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341223REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341247REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341254REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341261REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
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