FDA.reportPublic FDA data

Surtex

Primary DI
05056111322123
Brand
Surtex
Company
SURTEX INSTRUMENTS LTD.
Model
OP-274-12
Device description
"Foreign Body Needle Straight 12 cm - 4 3/4"" 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
HNASpud, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056111322123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056111322123050561113221235056111322123

GMDN Terms#

Term, Definition table
TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. 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

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Primary DI, Brand, Company table
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04251047903090Rosen Phaco SplitterA1 Medical GmbHHNA2026-06-09
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04251047913549Bechert Nucleus RotatorA1 Medical GmbHHNA2026-06-09
04251047928604Drysdale Nucleus ManipulatorA1 Medical GmbHHNA2026-06-09
00041533986539Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00041533996538Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00194613004521MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005344MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005351MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005368MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613030643MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
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00194613121792MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121969MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
G412PH60920MR PHACOCrestpoint Management LimitedHNA2025-06-07
G412PH60930MR PHACOCrestpoint Management LimitedHNA2025-06-07
00194613005337MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613005375MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613021139MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613039899MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613053932MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00757770408993Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770414284Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770418893Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00887482108628Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HNA2024-08-20
G586OP7125400Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
G586OP7125540Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
00190776355371MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776355388MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776069575AvalignAvalign Technologies, Inc.HNA2023-06-23