FDA.reportPublic FDA data

Surgical Design

Primary DI
00810055255115
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
OTT-16
Device description
Color-Coded Tuning Fork Set with Hammer
Published
2026-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWXFork, Tuning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWXFork, TuningNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055255115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055255115008100552551158100552551150810055255115

GMDN Terms#

Term, Definition table
TermDefinition
Urostomy bag/support kitA collection of devices intended to be used for attachment/replacement of a urostomy bag (for collecting urine following a urostomy procedure). It includes not only the urostomy bag and base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
112617522
Device count
1
Premarket exempt
true
Lot or batch
true
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
00190776423810MillenniumAvalign Technologies, Inc.GWX2026-08-26
04054462902200evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902224evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902231evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902248evonosevonos GmbH & Co. KGGWX2026-08-18
04054462902262evonosevonos GmbH & Co. KGGWX2026-08-18
09348811149084INKAThe Trustee for KAISER FAMILY TRUSTGWX2025-11-26
09348811110060INKAThe Trustee for KAISER FAMILY TRUSTGWX2025-11-21
00190776398231MillenniumAvalign Technologies, Inc.GWX2025-05-19
04049047025443GimmiGimmi GmbHGWX2025-05-06
00757770411702Bausch + LombBausch & Lomb IncorporatedGWX2024-12-23
G043630240BEARBear-Ent, LLCGWX2024-10-29
G043630250BEARBear-Ent, LLCGWX2024-10-29
G043630270BEARBear-Ent, LLCGWX2024-10-29
00887482116593Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116609Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116616Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116623Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.GWX2024-08-16
00887482116630Symmetry ForkASPEN SURGICAL PRODUCTS, INC.GWX2024-08-15
00887482103906Symmetry JannettaASPEN SURGICAL PRODUCTS, INC.GWX2024-08-02
00887482103913Symmetry JannettaASPEN SURGICAL PRODUCTS, INC.GWX2024-08-02
04049197305662RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305679RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305747RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305808RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305815RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28
04049197305822RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGWX2024-06-28