FDA.reportPublic FDA data

Clear View Black Belt II Ti Tilting Arm Retractor Basic Set

Primary DI
10840199501806
Brand
Clear View Black Belt II Ti Tilting Arm Retractor Basic Set
Company
KOROS U.S.A., INC.
Model
7320-00TU
Catalog number
7320-00TU
Device description
Clear View Black Belt II Ti Tilting Arm Retractor Basic Set Consists of the Following:1x 7320-10TU - Black Belt II Ti Tilting Arm Retractor Frame Right, 1x 7320-20TU - Black Belt II Ti Tilting Arm Retractor Frame Left, 1x 7320-30TU - Black Belt II Ti Tilting Arm Retractor Frame Offset, 2x 7320-40T - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34T - Black Belt Blade Ti Pronged 34mm, 2x 7322-40T - Black Belt Blade Ti Pronged 40mm, 2x 7322-45T - Black Belt Blade Ti Pronged 45mm, 2x 7322-50T - Black Belt Blade Ti Pronged 50mm, 2x 7322-55T - Black Belt Blade Ti Pronged 55mm, 2x 7322-60T - Black Belt Blade Ti Pronged 60mm, 2x 7322-70T - Black Belt Blade Ti Pronged 70mm, 2x 7324-34T - Black Belt Blade Ti Blunt 34mm, 2x 7324-40T - Black Belt Blade Ti Blunt 40mm, 2x 7324-45T - Black Belt Blade Ti Blunt 45mm, 2x 7324-50T - Black Belt Blade Ti Blunt 50mm, 2x 7324-55T - Black Belt Blade Ti Blunt 55mm, 2x 7324-60T - Black Belt Blade Ti Blunt 60mm, 2x 7324-70T - Black Belt Blade Ti Blunt 70mm, 4x 7326-40T - BB Two-Level Blade Ti Pronged 40mm, 4x 7326-47T - BB Two-Level Blade Ti Pronged 47mm, 4x 7326-55T - BB Two-Level Blade Ti Pronged 55mm, 2x 7328-40T - BB Two-Level Blade Ti Blunt 40mm, 2x 7328-47T - BB Two-Level Blade Ti Blunt 47mm, 2x 7328-55T - BB Two-Level Blade Ti Blunt 55mm, 1x 7320-90 - Black Belt Retractor Instrument Case
Published
2021-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935529000CERVICAL SELF-RETAINING RETRACTORT. Korossurgical Instruments Corp.1994-03-22GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199501809Direct MarkingGS10
10840199501806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199501809008401995018098401995018090840199501809
1084019950180610840199501806

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

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