FDA.reportPublic FDA data

Surgical Design

Primary DI
00810055258840
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
2908-10
Device description
Emmett Fistula Hook - 10 in.
Published
2026-05-29
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
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055258840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055258840008100552588408100552588400810055258840

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B7685252430Buxton BioMedicalBuxton Biomedical IncGDG2026-06-05
G383S1061WM3245624S7SURJEXSURJEXGDG2026-05-31
00810055258734Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258741Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258758Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258765Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258772Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258789Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258796Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258802Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258819Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258826Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258833Surgical DesignSurgical Design, Inc.GDG2026-05-29
09348811019622INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
09348811019639INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
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