FDA.reportPublic FDA data

Susol® Retractor Weitlaner 3 x 4 Blunt Prongs 16cm (Pack of 10)

Primary DI
05060418837181
Brand
Susol® Retractor Weitlaner 3 x 4 Blunt Prongs 16cm (Pack of 10)
Company
BAILEY INSTRUMENTS LTD
Model
SS25-2460
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
05060418837280PackageGS110In Commercial Distribution
05060418837181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060418837280050604188372805060418837280
05060418837181050604188371815060418837181

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
769260357
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060418834661Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833343Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833695Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418833725Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418833732Susol® Diamond Bur 15CS-DB72024-02-27
05060418833749Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418833992Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418834012Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418834029Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418833671Susol® Emery Board 18cmCH1452024-02-27
05060418832377Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418832407Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418832414Susol® Diamond Bur 15CS-DB72024-02-27
05060418832421Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418832674Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418832698Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418832704Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418836177Susol® Micro Curette Double Ended with holeSS62-43002024-02-27
05060418834883 Susol® Nail Care SetBSDP-022024-02-20
05060418833640 Susol® Nail Care SetBSDP-022024-02-20

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Primary DI, Brand, Company table
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