FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277392304
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
2773132RH
Catalog number
2773132RH
Device description
277-31-32 MANDIBULAR OSTEOTOMY SAFEDGE
Published
2025-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10888277392304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827739230410888277392304

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, reciprocating, reprocessedA flat surgical cutting instrument with a serrated edge, designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (not a dedicated sternum saw blade). It is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device that has previously been used on a patient and has been reprocessed for an additional single-use patient application.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD914455070Surgical DirectSurgical Direct, Inc.KDG2026-09-29
00810238290025PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713756PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713923PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713961PRINCETONPrinceton Medical Group, Inc.KDG2026-09-22
00850088713244PRINCETONPrinceton Medical Group, Inc.KDG2026-08-14
00198506093821ELMED INCORPORATEDELMED INCORPORATEDKDG2026-07-29
04059453095022Hermann Medizintechnik GmbHHermann Medizintechnik GmbHKDG2026-07-27
B382SD914455280Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD914457090Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD914457260Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD914458100Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD9144781000Surgical DirectSurgical Direct, Inc.KDG2026-07-27
B382SD9144781010Surgical DirectSurgical Direct, Inc.KDG2026-07-27
00850088713190PRINCETONPrinceton Medical Group, Inc.KDG2026-07-23
04059453127891Hermann Medizintechnik GmbHHermann Medizintechnik GmbHKDG2026-07-16
B382SD918006150Surgical DirectSurgical Direct, Inc.KDG2026-07-13
B382SD918006200Surgical DirectSurgical Direct, Inc.KDG2026-07-13
B382SD62622020Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622040Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622060Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622070Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622080Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622090Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622100Surgical DirectSurgical Direct, Inc.KDG2025-10-14
B382SD62622120Surgical DirectSurgical Direct, Inc.KDG2025-10-14
10840199528834Comfort Plus ChiselKOROS U.S.A., INC.KDG2025-01-31
10888277381339MEDLINEMEDLINE INDUSTRIES, INC.KDG2025-01-29
10840199511423ChiselKOROS U.S.A., INC.KDG2024-12-31
10840199511430ChiselKOROS U.S.A., INC.KDG2024-12-31