FDA.reportPublic FDA data

Surgical Design

Primary DI
00810055254064
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
ORG-153-02S
Published
2026-04-21
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055254064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055254064008100552540648100552540640810055254064

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Storage And Handling#

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

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
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
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
00190776432546MillenniumAvalign Technologies, Inc.HTX2026-09-28
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00190776431105MillenniumAvalign Technologies, Inc.HTX2026-09-21
00190776427955MillenniumAvalign Technologies, Inc.HTX2026-08-27
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
00840217909327Wiggins MedicalEBNER MEDICAL, LLCHTX2024-12-09
00840217908924Wiggins MedicalEBNER MEDICAL, LLCHTX2024-03-21