FDA.reportPublic FDA data

Medline

Primary DI
10888277394384
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
U551RH
Catalog number
U551RH
Device description
U551 @SAGITTAL & OSC STRGT BLADE 7.4MM X
Published
2021-09-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GETMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277394384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827739438410888277394384

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, reprocessedA flat surgical cutting instrument, usually made of high-grade stainless steel, 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 (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809317170671LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170701LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170817LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317171012LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170657LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170664LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170695LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170824LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08800038048270LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048287LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048294LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048300LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038053151LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038055421LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055438LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055445LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055469LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08809317170800LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048645LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038048652LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038055452LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
06946998817265BojinShanghai Bojin Electric Instrument & Device Co., Ltd.GET2022-12-29
05051471038820De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471047631De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471085596De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471098152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471105577De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471107397De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471107410De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471109773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28