FDA.reportPublic FDA data

SurgiMac

Primary DI
D105SKU1312100
Brand
SurgiMac
Company
Surgimac LLC
Model
13-1210
Catalog number
13-1210
Device description
10R, Spatulas, Pro Series.
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXRSpatula, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D105SKU1312100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060635048
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D1051217840MacBite12178-42025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14
D1057117M0MacTouch 7117-M2025-08-14
D1057117MCS1MacTouch 7117-M-CS2025-08-14
D1057118L0MacTouch 7118-L2025-08-14
D1057118LCS1MacTouch 7118-L-CS2025-08-14
D1057119XL0MacTouch 7119-XL2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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14035282341216REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
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14035282341247REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341254REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341261REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
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04026575341368LINK Instruments - Chisel, bone curette, raspatory, rongeurWALDEMAR LINK GmbH & Co. KGHXR2022-12-20
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00681490912235Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00681490912242Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00840319718230Hayden MedicalHayden Medical, Inc.HXR2022-08-03
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04251436928604KOHDENTKohler Medizintechnik GmbHHXR2021-09-22
04251436915178KOHDENTKohler Medizintechnik GmbHHXR2021-08-30
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