FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319759400
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
405-753
Catalog number
405-753
Device description
Tilley Ergo Retractor 8" (22cm) double-ended with micro-serrated blades. blade sizes: 5-3/8" x 1-3/4" (135 x 43mm) & 4-1/2" x 1" (115 x 24mm). Ergonomic light-weight handle.
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840319759400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319759400008403197594008403197594000840319759400

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
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
00840319759417Hayden Medical405-754405-7542026-09-04
00840319759424Hayden Medical405-374405-3742026-09-04
00840319759431Hayden Medical100-405SCK100-405SCK2026-09-04
00840319759325Hayden Medical115-070H115-070H2026-08-27
00840319759332Hayden Medical115-070115-0702026-08-25
00840319758229Hayden MedicalE3-2617E3-26172025-08-29
00840319759271Hayden MedicalE7-2157E7-21572026-08-14
00840319759202Hayden MedicalE5-6408E5-64082026-07-30
00840319759189Hayden MedicalE7-2134E7-21342026-06-24
00840319759035Hayden MedicalPWT1064PWT10642026-06-10
00840319759042Hayden MedicalH-1004H-10042026-06-04
00840319759059Hayden MedicalH-1004H-10042026-06-04
00840319759066Hayden MedicalH-20012026-06-04
00840319759073Hayden MedicalH-1002H-10022026-06-04
00840319759028Hayden MedicalE5-6459E5-64592026-05-15
00840319759004Hayden MedicalE7-2385E7-23852026-05-13
00840319759011Hayden Medical405-450S405-450S2026-05-01
00840319757987Hayden Medical405-463CS405-463CS2026-04-23
00840319758977Hayden Medical405-466CS405-466CS2026-04-23
00840319758984Hayden Medical405-470405-4702026-04-22

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Primary DI, Brand, Company table
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00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
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