FDA.reportPublic FDA data

Surtex

Primary DI
05055445927172
Brand
Surtex
Company
SURTEX INSTRUMENTS LTD.
Model
RT-961-02
Device description
Caspar Hook Depth 58 mm Stainless Steel
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
05055445927172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055445927172050554459271725055445927172

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+442081233513qa@surtex-instruments.co.uk

Regulatory Flags#

DUNS number
216232502
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055445900007SurtexSL-010-032026-05-12
05055445900014SurtexSL-010-042026-05-12
05055445900021SurtexSL-010-342026-05-12
05055445900038SurtexSL-012-032026-05-12
05055445900045SurtexSL-020-132026-05-12
05055445900052SurtexSL-020-142026-05-12
05055445900069SurtexSL-021-132026-05-12
05055445900076SurtexSL-021-142026-05-12
05055445900083SurtexSL-030-072026-05-12
05055445900090SurtexSL-030-172026-05-12
05055445900106SurtexSL-032-082026-05-12
05055445900113SurtexSL-032-092026-05-12
05055445900120SurtexSL-050-032026-05-12
05055445900137SurtexSL-052-032026-05-12
05055445900144SurtexSL-053-032026-05-12
05055445900151SurtexSL-056-032026-05-12
05055445900342SurtexSL-150-002026-05-12
05055445900359SurtexSL-200-002026-05-12
05055445900366SurtexSL-202-002026-05-12
05055445900373SurtexSL-204-002026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395674MillenniumAvalign Technologies, Inc.GDG2026-07-14
00810158216136PRINCETONPrinceton Medical Group, Inc.GDG2026-06-23
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
00810055258840Surgical 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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