FDA.reportPublic FDA data

Surgical Design

Primary DI
00810055257652
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
DMC-4
Device description
Laryngoscope Blade #4, Mac, Disposable
Published
2026-06-10
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055257652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055257652008100552576528100552576520810055257652

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use 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
false
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
00810055255184Surgical DesignSD-DS-SS-10-BX2026-09-26
00810055255191Surgical DesignSD-DS-SS-11-BX2026-09-26
00810055255207Surgical DesignSD-DS-SS-12-BX2026-09-26
00810055255214Surgical DesignSD-DS-SS-12B-BX2026-09-26
00810055255238Surgical DesignSD-DS-SS-15-BX2026-09-26
00810055255245Surgical DesignSD-DS-SS-21-BX2026-09-26
00810055255252Surgical DesignSD-DS-SS-22-BX2026-09-26
00810055255269Surgical DesignSD-DS-SS-23-BX2026-09-26
00810055255276Surgical DesignSD-DS-SS-24-BX2026-09-26
00810055255283Surgical DesignSD-DS-SS-20-BX2026-09-26
00810055255290Surgical DesignSD-SB-CS-10-BX2026-09-26
00810055255313Surgical DesignSD-SB-CS-11-BX2026-09-26
00810055255320Surgical DesignSD-SB-CS-12-BX2026-09-26
00810055255337Surgical DesignSD-SB-CS-12B-BX2026-09-26
00810055255368Surgical DesignSD-SB-CS-15-BX2026-09-26
00810055255382Surgical DesignSD-SB-CS-15C-BX2026-09-26
00810055255429Surgical DesignSD-SB-CS-20-BX2026-09-26
00810055255436Surgical DesignSD-SB-CS-21-BX2026-09-26
00810055255443Surgical DesignSD-SB-CS-22-BX2026-09-26
00810055255450Surgical DesignSD-SB-CS-23-BX2026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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