FDA.report

Alta ACDF System

Primary DI
03662663254939
Brand
Alta ACDF System
Company
Highridge Medical, LLC
Model
8633-0025
Catalog number
8633-0025
Device description
Grooved Soft Tissue Retractor
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663254939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663254939036626632549393662663254939

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags

DUNS number
119260394
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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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