FDA.reportPublic FDA data

Surgical Design

Primary DI
00810189450691
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
ATPM-003
Device description
Virchow Brain Sectioning Knife 180x20mm Double Edge
Published
2026-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810189450691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189450691008101894506918101894506910810189450691

GMDN Terms#

Term, Definition table
TermDefinition
Brain knifeA hand-held manual surgical instrument with a handle and an extra long, broad blade used during an autopsy to slice evenly across the entire brain mass of a cadaver to obtain clean cut, cross-sectional, pathological samples. It is typically a one-piece instrument made of high-grade stainless steel; the blade is very broad and thin with a rounded tip. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7035410196info@surgical-design.com

Regulatory Flags#

DUNS number
112617522
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055251520Surgical DesignCSS-55-01TC2026-06-06
00810055251537Surgical DesignCSS-55-02TC2026-06-06
00810055251544Surgical DesignCSS-55-03TC2026-06-06
00810055251551Surgical DesignCSS-55-04TC2026-06-06
00810055257874Surgical Design785-1422026-06-06
00810055257881Surgical Design785-1252026-06-06
00810055257898Surgical Design785-1262026-06-06
00810055257904Surgical Design785-1272026-06-06
00810055257911Surgical Design785-1282026-06-06
00810055257928Surgical Design785-1292026-06-06
00810055257935Surgical Design785-1302026-06-06
00810055257942Surgical Design785-1312026-06-06
00810189450707Surgical DesignATPM-0042026-06-06
00810189450714Surgical DesignATPM-0052026-06-06
00810189450721Surgical DesignATPM-0062026-06-06
00810189450738Surgical DesignATPM-0072026-06-06
00810189450752Surgical DesignATPM-0092026-06-06
00810189450783Surgical DesignATPM-0122026-06-06
00810189450790Surgical DesignATPM-0132026-06-06
00810189450806Surgical DesignATPM-0142026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189450707Surgical DesignSurgical Design, Inc.EMF2026-06-06
00198506085659ELMED INCORPORATEDELMED INCORPORATEDEMF2025-10-02
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
00860010523902VECTRRafael Medical Devices, LLCEMF2025-01-10
00842180160613ELMEDELMED INCORPORATEDEMF2023-01-30
00842180147737ELMEDELMED INCORPORATEDEMF2022-12-22
14026704810861PILLINGTELEFLEX INCORPORATEDEMF2022-12-08
00192896113701Cottle Mucosa KnifeSONTEC INSTRUMENTS, INC.EMF2022-09-15
00847399017239MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
00847399017246MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
00847399016003MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016010MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016034MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016935MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016942MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
20630140057523CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
20630140057530CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
00848782025527StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025541StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025572StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025602StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025633StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025657StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025671StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025688StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025763StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025787StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29