FDA.report

PRIMA

Primary DI
08033390268493
Brand
PRIMA
Company
LIMACORPORATE SPA
Model
9013.67.167
Catalog number
9013.67.167
Device description
PRIMA - Metaphyseal Size Ring #7
Published
2024-07-27
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

Product Codes

CodeName
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications

CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390268493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390268493080333902684938033390268493

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
432066322
Device count
1
DM exempt
false
Premarket exempt
false
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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08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
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08033390202312PRIMA1367.09.2701367.09.2702026-02-19
08033390202466PRIMA1367.09.2731367.09.2732026-02-19
08033390202473PRIMA1367.09.2761367.09.2762026-02-19
08033390202480PRIMA1367.09.4031367.09.4032026-02-19
08033390202497PRIMA1367.09.4061367.09.4062026-02-19
08033390202503PRIMA1367.09.3001367.09.3002026-02-19
08033390202602PRIMA1367.09.3031367.09.3032026-02-19
08033390202619PRIMA1367.09.3061367.09.3062026-02-19

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Primary DIBrandCompanyProduct codePublished
08033390002233SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAPHX2026-02-19
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08033390050036SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390191135PRIMALIMACORPORATE SPAPHX2026-02-19
08033390201971PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202299PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202305PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202312PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202466PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202473PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202480PRIMALIMACORPORATE SPAPHX2026-02-19
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08033390202602PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202619PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202626PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202633PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202640PRIMALIMACORPORATE SPAPHX2026-02-19
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08033390248624PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
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