FDA.reportPublic FDA data

Surgical Design

Primary DI
00810189451537
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
11-1363
Device description
Wire End Cutter, 6.25 in. Double Action
Published
2026-05-23
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
HTCPliers, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810189451537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189451537008101894515378101894515370810189451537

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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
00810055250547Surgical Design141-07R-BL2026-05-26
00810055256211Surgical Design141-07-O2026-05-26
00810055256235Surgical Design141-07-PK2026-05-26
00810055256242Surgical Design141-07-RD2026-05-26
00810055256259Surgical Design141-07-YW2026-05-26
00810055258604Surgical Design141-07R2026-05-26
00810055258611Surgical Design141-07R-RD2026-05-26
00810055258628Surgical Design141-07R-GR2026-05-26
00810055258635Surgical Design141-07R-PK2026-05-26
00810055258642Surgical Design141-07R-PR2026-05-26
00810055258659Surgical Design141-07R-WH2026-05-26
00810055258666Surgical Design141-07R-TL2026-05-26
00810055258673Surgical Design141-07R-WY2026-05-26
00810055258680Surgical Design141-07F2026-05-26
00810055258697Surgical Design141-07-BL2026-05-26
00810055258703Surgical Design141-07-GR2026-05-26
00810055258710Surgical Design141-07-PR2026-05-26
00810055258727Surgical Design141-07-WH2026-05-26
00810055259663Surgical Design159R2026-05-26
00810055259670Surgical Design160R2026-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71180TBS BASICSACME ENTERPRISE.HTC2026-05-22
G149TBSB71190TBS BASICSACME ENTERPRISE.HTC2026-05-22
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03662663217651Posterior Cervical Removal InstrumentsHighridge Medical, LLCHTC2025-12-17
00840314270207gSourceGSOURCE LLCHTC2025-11-17
00840314270214gSourceGSOURCE LLCHTC2025-11-17
00885556908860EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911570EVOSSmith & Nephew, Inc.HTC2025-11-11
00885556911587EVOSSmith & Nephew, Inc.HTC2025-11-11
00841336106109Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106116Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106123Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
00841336106130Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHTC2025-09-28
08033390289061ArTTLIMACORPORATE SPAHTC2025-09-25
B356KE334280American MedicalsAmerican MedicalsHTC2025-09-15
B356KJ522130American MedicalsAmerican MedicalsHTC2025-09-12
00841435111080TecometTECOMET INC.HTC2025-08-27
00841435111103TecometTECOMET INC.HTC2025-08-27
00841435111127TecometTECOMET INC.HTC2025-08-27
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00841435111141TecometTECOMET INC.HTC2025-08-27
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00841435111172TecometTECOMET INC.HTC2025-08-27
00841435111189TecometTECOMET INC.HTC2025-08-27
00841435111202TecometTECOMET INC.HTC2025-08-27
00841435118263TecometTECOMET INC.HTC2025-08-27
00841435118287TecometTECOMET INC.HTC2025-08-27
00841435118317TecometTECOMET INC.HTC2025-08-27
00840105223801ZOLL DENTALZoll-DentalHTC2025-08-11