FDA.reportPublic FDA data

HV Heart Retractor Blade

Primary DI
00850037179770
Brand
HV Heart Retractor Blade
Company
USB Medical Limited
Model
HVC-S22
Catalog number
HVC-S22
Device description
HV Heart Retractor Blade / Paddle Small Double Hinge
Published
2025-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037179770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037179770008500371797708500371797700850037179770

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

Regulatory Flags#

DUNS number
018543576
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037179015USB Delivery Forceps - ExtendedDF-102DF-1022026-04-09
00850037179039USB G2 Detachable Vascular Clamp System - 60mm Straight ArmG2-2803G2-28032026-04-09
00850037180011USB Delivery Forceps - ExtendedDF-102DF-1022026-01-27
00850037180004USB G2 Detachable Vascular Clamp System - 60mm Straight ArmG2-2803G2-28032026-01-07
00850037179886USB G2 Detachable Vascular Clamp System - 40mm Curved Arm SetG2-2401G2-24012026-01-06
00850037179893USB G2 Detachable Vascular Clamp System - 40mm Straight ArmG2-2403G2-24032026-01-06
00850037179909USB G2 Detachable Vascular Clamp System - Right Angle ArmG2-2451G2-24512026-01-06
00850037179916USB G2 Detachable Vascular Clamp System - 60mm Curved ArmG2-2601G2-26012026-01-06
00850037179923USB G2 Detachable Vascular Clamp System - 60mm Straight ArmG2-2603G2-26032026-01-06
00850037179930USB G2 Detachable Vascular Clamp System - 80mm Curved ArmG2-2801G2-28012026-01-06
00850037179947USB G2 Detachable Vascular Clamp System - 94mm Gentle Curved ArmG2-2941G2-29412026-01-06
00850037179954USB G2 Detachable Vascular Clamp System - 95mm Straight ArmG2-2951G2-29512026-01-06
00850037179961USB G2 Detachable Vascular Clamp SystemG2-1000 4G2-1000 42026-01-06
00850037179978USB G2 Detachable Vascular Clamp SystemG2-1000 3G2-1000 3 2026-01-06
00850037179985USB G2 Detachable Vascular Clamp SystemG2-1000 4XLG2-1000 4XL2026-01-06
00850037179992USB G2 Detachable Vascular Clamp System - 93mm Curved ArmG2-2931G2-29312026-01-06
00850037179763HV Heart Retractor Blade HVC-S24HVC-S242025-08-21
00850037179787HV Heart Retractor Blade HVC-S42HVC-S422025-08-21
00850037179794HV Heart Retractor Blade HVC-S44HVC-S442025-08-21
00850037179800HV Heart Retractor Blade HVC-S52HVC-S522025-08-21

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