FDA.report

Stabilizer Clamp

Primary DI
00840199536641
Brand
Stabilizer Clamp
Company
KOROS U.S.A., INC.
Model
8760-25
Catalog number
8760-25
Device description
Stabilizer Clamp
Published
2024-01-31
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

Related Records

Contact Domains

Product Codes

CodeName
MWSStabilizer, Heart

Product Code Classifications

CodeDeviceSpecialtyClass
MWSStabilizer, HeartCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840199536641Direct MarkingGS10
10840199536648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199536641008401995366418401995366410840199536641
1084019953664810840199536648

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

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