PONTiS Achilles Tendon Repair System

Primary DI
00859210006070
Brand
PONTiS Achilles Tendon Repair System
Company
PONTIS ORTHOPAEDICS, LLC
Model
600-4001
Catalog number
600-4001
Device description
PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp.Each Kit contains:1x size #3 MFSS suture with 2 curved needles (white wrap)1x size #3 MFSS suture with 2 curved needles (black wrap)1x SS Crimp Collar for #3 SS suturesSupplied pouched, sterilized with EO.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859210006070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859210006070008592100060708592100060700859210006070

GMDN Terms#

Term, Definition table
TermDefinition
Metallic suture, multifilamentA sterile, multiple-strand (multifilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached needle intended to be disposed of after single use. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
415-567-8935info@pontisorthopaedics.com

Regulatory Flags#

DUNS number
047775061
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859210006001PONTiS Flexor Tendon Repair System400-3011400-30112016-09-01
00859210006032PONTiS Flexor Tendon Repair System401-3006401-30062016-09-01
00859210006117PONTiS Suture-Crimp Implant400-3020400-30202017-09-12
00859210006018PONTiS Flexor Tendon Repair System400-3014400-30142016-09-01
08592110006100PONTiS Suture-Crimp Implant400-3019400-30192016-11-18
00859210006025PONTiS Flexor Tendon Repair System400-3031400-30312016-09-01
00859210006049PONTiS Flexor Tendon Repar System400-3015400-30152016-09-01

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