FDA.reportPublic FDA data

Surtex

Primary DI
05055445957193
Brand
Surtex
Company
SURTEX INSTRUMENTS LTD.
Model
OP-550-03
Device description
"Meyerhoefer Chalazion Curette Size 3 12.5 cm - 5"" Dia. 2.5 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
FZSCURETTE, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055445957193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055445957193050554459571935055445957193

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use 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
B382SD9147092060Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092120Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092130Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096470Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096520Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
04046963939588NOVOCARTAesculap AGFZS2020-04-24
04046963315511NOVOCARTAesculap AGFZS2020-04-23
04046963315528NOVOCARTAesculap AGFZS2020-04-23
10649111094002SklarSKLAR CORPORATIONFZS2019-08-26
10649111094088SklarSKLAR CORPORATIONFZS2019-08-26
10649111217210SklarSKLAR CORPORATIONFZS2019-03-15
10649111217494SklarSKLAR CORPORATIONFZS2019-03-15
10649111217586SklarSKLAR CORPORATIONFZS2019-03-15
10649111217838SklarSKLAR CORPORATIONFZS2019-03-15
10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
10649111017858SklarSKLAR CORPORATIONFZS2019-03-13
10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
10649111018282SklarSKLAR CORPORATIONFZS2019-03-13
10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13
10649111161964SklarSKLAR CORPORATIONFZS2019-03-13
10649111162060SklarSKLAR CORPORATIONFZS2019-03-13