FDA.reportPublic FDA data

Surtex

Primary DI
05055445975289
Brand
Surtex
Company
SURTEX INSTRUMENTS LTD.
Model
OM-279-30
Device description
"Obwegeser Mandibular Retractor 21 cm - 8 1/4"" Blade Size 12 x 30 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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055445975289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055445975289050554459752895055445975289

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040548SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040555SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040579SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040586SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040593SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040609SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040616SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040623SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00841536147230ThompsonThompson Surgical Instruments, Inc.GAD2026-06-03
00846159040388SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040395SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040401SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040418SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040432SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040449SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040456SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040463SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040470SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040487SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040494SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040500SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040517SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03