FDA.reportPublic FDA data

ROYAL TEK

Primary DI
00810055256853
Brand
ROYAL TEK
Company
Surgical Design, Inc.
Model
DC03-10
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055256853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055256853008100552568538100552568530810055256853

GMDN Terms#

Term, Definition table
TermDefinition
Dermal curette, single-useA hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit72 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
112617522
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055251339Surgical DesignCLH-LG2026-06-09
00810055251346Surgical DesignCLH-MD2026-06-09
00810055251353Surgical DesignCLH-SM2026-06-09
00810055251360Surgical DesignCMC-02026-06-09
00810055251377Surgical DesignCMC-002026-06-09
00810055251384Surgical DesignCMC-12026-06-09
00810055251391Surgical DesignCMC-22026-06-09
00810055251414Surgical DesignCMC-42026-06-09
00810055251421Surgical DesignCMC-52026-06-09
00810055251445Surgical DesignCML-02026-06-09
00810055251452Surgical DesignCML-002026-06-09
00810055251469Surgical DesignCML-12026-06-09
00810055251476Surgical DesignCML-22026-06-09
00810055251483Surgical DesignCML-32026-06-09
00810055251490Surgical DesignCML-42026-06-09
00810055251506Surgical DesignCML-52026-06-09
00810055257744Surgical DesignDFLS-05MC2026-06-09
00810055257768Surgical DesignDFLS-05ML2026-06-09
00810055257782Surgical DesignDFLS-122026-06-09
00810055251520Surgical DesignCSS-55-01TC2026-06-06

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