FDA.reportPublic FDA data

Poly-Tape 30mm x 800mm

Primary DI
05060267131812
Brand
Poly-Tape 30mm x 800mm
Company
XIROS LTD
Model
102-1083
Catalog number
n/a
Published
2023-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
JDRStaple, Fixation, Bone
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
JDRStaple, Fixation, BoneOrthopedic2
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of LigamentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010051000
K222978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010051000POLY-TAPES WITH THE FASTLOK FIXATION DEVICEXiros Plc2001-07-13JDR
K222978000Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.2022-12-27QUW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060267131812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060267131812050602671318125060267131812

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401132387202enquiries@neoligaments.com
+4401132387202enquiries@xiros.co.uk

Regulatory Flags#

DUNS number
228209805
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060267132499Poly-Tape 5 mm x 800 mm 102-1086102-10862022-10-14
05060267132505Poly-Tape 7 mm x 800 mm 102-1087102-10872022-10-14
05060267132512Poly-Tape 10 mm x 800 mm 102-1080102-10802022-10-14
05060267132529Poly-Tape 15 mm x 800 mm 102-1081102-10812022-10-14
05060267132536Poly-Tape 20 mm x 800 mm 102-1082102-10822022-10-14
05060267132543Infinity-Lock 3102-1100102-11002022-10-14
05060267132550Infinity-Lock 5102-1101102-11012022-10-14
05060267132567Infinity-Lock 7 102-1102102-11022022-10-14
05060267131928Infinity-Lock 3102-1100102-11002020-06-04
05060267131935Infinity-Lock 5102-1101102-11012020-06-04
05060267130365Poly-Tape 10 mm x 500 mm102-1010n/a2015-10-09
05060267130372Poly-Tape 15 mm x 500 mm102-1011n/a2015-10-09
05060267130389Poly-Tape 20 mm x 500 mm102-1012n/a2015-10-09
05060267130402Poly-Tape 30 mm x 500 mm102-1013n/a2015-10-09
05060267130433Poly-Tape (dia. 5 mm) x 500 mm (TUBE)102-1040n/a2015-10-09
05060267130471Poly-Tape 10 mm x 800 mm102-1080n/a2015-10-09
05060267130488Poly-Tape 15 mm x 800 mm102-1081n/a2015-10-09
05060267130495Poly-Tape 20 mm x 800 mm102-1082n/a2015-10-09
05060267130501Poly-Tape 30 mm x 800 mm102-1083n/a2015-10-09
05060267130563AchilloCordPLUS102-1144n/a2015-10-09

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