FDA.reportPublic FDA data

REMA Shaver Blades

Primary DI
14035282341803
Brand
REMA Shaver Blades
Company
DEWIMED Medizintechnik GmbH
Model
15-61540
Catalog number
15-61540
Device description
INCISOR 5,5 Ø MM AUTOKLAVIERBAR
Published
2025-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059223160103PrimaryGS10
14035282341803Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059223160103040592231601034059223160103
1403528234180314035282341803

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
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
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
14035282341827REMA Shaver Blades15-6156015-615602025-02-27

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Primary DI, Brand, Company table
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00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
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00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
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