FDA.reportPublic FDA data

PANACRYL

Primary DI
20886705002174
Brand
PANACRYL
Company
DEPUY MITEK, LLC
Model
212731
Catalog number
212731
Device description
Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with CP-2 needles on disposable inserter
Published
2017-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915889000MITEK BONE ANCHOR, MODIFICATIONMitek Surgical Products, Inc.1992-10-22JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886705002174PackageGS15Not in Commercial Distribution
10886705002177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670500217420886705002174
1088670500217710886705002177

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius
Handling Environment Temperature077 Degrees Fahrenheit
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature077 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705022397INTRAFIX2546532546532015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
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00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593143TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
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00810112593198TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22