NA

Primary DI
10885862090225
Brand
NA
Company
Exactech, Inc.
Model
400-30-20
Catalog number
400-30-20
Device description
STRAIGHT REAMER
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSZInstrument, surgical, orthopedic, pneumatic powered & accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862090225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586209022510885862090225

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn 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 table
Method

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
Primary DIBrandModelCatalogPublished
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26
10885862653826Alteon190-00-14190-00-142026-05-26
10885862653833Alteon190-00-15190-00-152026-05-26
10885862653840Alteon190-01-02190-01-022026-05-26
10885862653857Alteon190-01-03190-01-032026-05-26
10885862653864Alteon190-01-04190-01-042026-05-26
10885862653871Alteon190-01-05190-01-052026-05-26
10885862653888Alteon190-01-06190-01-062026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919964308Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971733Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971764Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971795Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00763000714635MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
00763000865627MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
08800017288376LOSPA IS Spinal SystemCorentec Co., LtdHSZ2022-10-21
10885862090454AcudriverExactech, Inc.HSZ2022-09-19
10885862090560NAExactech, Inc.HSZ2022-09-19
00847399004338MicroAire® Microaire Surgical Instruments LLCHSZ2022-09-17
00847399004765MicroAire® Microaire Surgical Instruments LLCHSZ2022-09-01
10885862090232NAExactech, Inc.HSZ2022-07-28
10885862090256NAExactech, Inc.HSZ2022-07-28
10885862090263NAExactech, Inc.HSZ2022-07-28
10885862090362NAExactech, Inc.HSZ2022-07-28
10885862090379NAExactech, Inc.HSZ2022-07-28
10885862090416NAExactech, Inc.HSZ2022-07-28
10885862090423NAExactech, Inc.HSZ2022-07-28
10885862090430NAExactech, Inc.HSZ2022-07-28
10885862090485NAExactech, Inc.HSZ2022-07-28
10885862090492NAExactech, Inc.HSZ2022-07-28
10885862090508NAExactech, Inc.HSZ2022-07-28
10885862090522NAExactech, Inc.HSZ2022-07-28
10885862090539NAExactech, Inc.HSZ2022-07-28
10885862090546NAExactech, Inc.HSZ2022-07-28
00763000513443MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
00763000513450MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
00763000513832MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22
00763000513863MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22
00763000513870MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22