FDA.report

Lateral Retractor

Primary DI
10889981099503
Brand
Lateral Retractor
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
95-6915
Catalog number
95-6915
Device description
Center Blade, 120mm
Published
2016-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981099503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088998109950310889981099503

GMDN Terms

TermDefinition
Orthopaedic retractorA hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags

DUNS number
079840876
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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