FDA.report

Disc Prep

Primary DI
10889981102012
Brand
Disc Prep
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
06-20-0115
Catalog number
06-20-0115
Device description
15mm Shaver
Published
2016-05-02
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
HTRRASP

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981102012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088998110201210889981102012

GMDN Terms

TermDefinition
Bone fileA hand-held, manually-operated, instrument that has various forms of fine ridged cutting surfaces along part of or all of its working end that is used for cutting and smoothing (filing) bone tissue. It is made of high-grade steel and may be a one-piece instrument with a handle at the proximal end. The distal end may be flat or profiled (e.g., flat on one side and convex on the other). This device is typically used in orthopaedics, plastic surgery and dentistry. 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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