FDA.reportPublic FDA data

SharpShooter® Surgical Suture

Primary DI
M928HS47041
Brand
SharpShooter® Surgical Suture
Company
IVY SPORTS MEDICINE LLC
Model
HS4704
Catalog number
HS4704
Device description
UHMWPE Suture for SharpShooter®
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M928HS47042PackageHIBCC10Not in Commercial Distribution
M928HS47041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. 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
1-800-624-4422endocustomersupport@stryker.com

Regulatory Flags#

DUNS number
046226406
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M92847011SharpShooter® Surgical Suture470147012015-10-24
M92843001Collagen Meniscus Implant CMI®Medial 7.5 mm43002015-10-24
M92843011Collagen Meniscus Implant CMI®Medial 9.0 mm43012015-10-24
M92843021Collagen Meniscus Implant CMI®Medial XL43022017-08-14
M92847012SharpShooter® Surgical Suture470147012015-10-24
M92847201Stryker AIR™472047202017-01-13
M92847301IvyAIR Meniscus System, Curved473047302016-08-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
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