FDA.reportPublic FDA data

Elevator

Primary DI
00857915007651
Brand
Elevator
Company
A.M. SURGICAL, INC.
Model
9600-06
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857915007651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857915007651008579150076518579150076510857915007651

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Regulatory Flags#

DUNS number
160020087
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857915007047RETRA5500-RN/A2026-05-20
00857915007040RETRA5500-SR2026-05-20
00857915007668Dilator-Small9600-072026-05-20
00857915007675Dilator-Medium9600-082026-05-20
00857915007682Dilator-Large9600-092026-05-20
00857915007699Locking Attachment9600-042026-05-20
00857915007286Secure IM Nail8960-652019-11-14
00857915007293Secure IM Nail8960-702019-11-14
00857915007309Secure IM Nail8912-302019-11-14
00857915007316Secure IM Nail8912-352019-11-14
00857915007323Secure IM Nail8912-402019-11-14
00857915007330Secure IM Nail8912-452019-11-14
00857915007347Secure IM Nail8912-502019-11-14
00857915007354Secure IM Nail8912-552019-11-14
00857915007361Secure IM Nail8912-602019-11-14
00857915007378Secure IM Nail8912-652019-11-14
00857915007385Secure IM Nail8912-702019-11-14
00857915007057Secure IM Nail8960-402018-07-16
00857915007064Secure IM Nail8960-452018-07-16
00857915007071Secure IM Nail8960-502018-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
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10381780503248Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503361Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503378Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503606Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10649111225628SklarSKLAR CORPORATIONGEG2019-08-02
10649111452826SklarSKLAR CORPORATIONGEG2019-05-13
10381780495888Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-10-24
10381780509523Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-10-23
10381780499671Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499688Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499695Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499701Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499718Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780506522Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-12
10381780506539Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-12
10381780487791Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-20
10381780487838Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-20
10381780487982Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-20
10381780423997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780424116Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780445517Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780407706Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-03
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401285Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401292Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780409779Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02