NA

Primary DI
10885862090409
Brand
NA
Company
Exactech, Inc.
Model
400-40-20
Catalog number
400-40-20
Device description
FLEX OSTEOTOME-FLAT, NAR
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
KDGCHISEL (OSTEOTOME)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862090409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586209040910885862090409

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement extractor, electricA hand-operated, electrically-powered surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other power operated devices which are intended to be used to break up the bone cement for removal. 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
B382SD914459320Surgical DirectSurgical Direct, Inc.KDG2026-02-25
B382SD914031000Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914031010Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914456290Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663010Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663020Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663030Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663040Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD914591000Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD921648100Surgical DirectSurgical Direct, Inc.KDG2026-02-09
00810158218635PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218734PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218499PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
00810158218536PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
B382SD48820520Surgical DirectSurgical Direct, Inc.KDG2025-12-02
00810158218086PRINCETONPrinceton Medical Group, Inc.KDG2025-11-24
00810158217393PRINCETONPrinceton Medical Group, Inc.KDG2025-09-29
B382SD9219563010Surgical DirectSurgical Direct, Inc.KDG2025-09-22
B382SD936682100Surgical DirectSurgical Direct, Inc.KDG2025-09-18
B382SD9146891000Surgical DirectSurgical Direct, Inc.KDG2025-09-12
00810158216471PRINCETONPrinceton Medical Group, Inc.KDG2025-08-21
00810158215894PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216044PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216051PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216068PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216075PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216082PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
B382SD921381020Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646030Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646040Surgical DirectSurgical Direct, Inc.KDG2025-08-11