Suture Retaining Bar, Single Use, Sterile

Primary DI
10840199536730
Brand
Suture Retaining Bar, Single Use, Sterile
Company
KOROS U.S.A., INC.
Model
8782-00
Catalog number
8782-00
Device description
"Suture Retaining Bar 9"" Bar Length, 10 Packages of 3 Per Box, Single Use Only"
Published
2023-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10840199536730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084019953673010840199536730

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
007928633
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

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