FDA.report

Mold

Primary DI
09120047307472
Brand
Mold
Company
I.T.S. GmbH
Model
67181-14
Catalog number
67181-14
Device description
Mold, PRS, 14-Hole, Straight
Published
2018-10-23
Public version status
Update
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

Product Codes

CodeName
HWTTemplate

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09120047307472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09120047307472091200473074729120047307472

GMDN Terms

TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
303456917
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
09120047301241Cannulated Tibia Nail11210-36011210-3602016-09-14
09120047301364Cannulated Tibia Nail11209-28511209-2852016-09-14
09120047301371Cannulated Tibia Nail11209-30011209-3002016-09-14
09120047301388Cannulated Tibia Nail11209-40511209-4052016-09-14
09120047301395Cannulated Tibia Nail11210-28511210-2852016-09-14
09120047301418Cannulated Tibia Nail11209-33011209-3302016-09-14
09120047301425Cannulated Tibia Nail11209-34511209-3452016-09-14
09120047301432Cannulated Tibia Nail11209-36011209-3602016-09-14
09120047301449Cannulated Tibia Nail11209-37511209-3752016-09-14
09120047301456Cannulated Tibia Nail11209-39011209-3902016-09-14
09120047301692Cannulated Tibia Nail11210-31511210-3152016-09-14
09120047301722Cannulated Tibia Nail11210-33011210-3302016-09-14
09120047301739Cannulated Tibia Nail11210-34511210-3452016-09-14
09120047301968Cannulated Tibia Nail11209-31511209-3152016-09-14
09120047302118Cannulated Tibia Nail11210-39011210-3902016-09-14
09120047302156Cannulated Femur Nail, Right12110-30012110-3002016-09-14
09120047302163Cannulated Femur Nail, Left12210-30012210-3002016-09-14
09120047302194Cannulated Femur Nail, Right12112-30012112-3002016-09-14
09120047302200Cannulated Femur Nail, Left12212-30012212-3002016-09-14
09120047303214Cannulated Femur Nail, Right12112-42012112-4202016-09-14

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