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Primary DI
00860323000206
Brand
Xclose Plus
Company
Kr Medical Technologies LLC
Model
XC-201-01
Catalog number
XC-201-01
Device description
TISSUE REPAIR SYSTEM WITH INVISILOC TECHNOLOGY
Published
2015-10-24
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091432000XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01Anulex Technologies, Inc.2009-06-12GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860323000206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860323000206008603230002068603230002060860323000206

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polyethylene) 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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-326-8539customerservice@krmedtech.com

Regulatory Flags#

DUNS number
030742286
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653900497PremicronB BRAUN SURGICAL SAGAT2015-11-11
04038653914050PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653921980PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991822PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003853PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003914PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003921PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439020690PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991785PremicronB BRAUN SURGICAL SAGAT2015-11-05
10884521072657V-LocCovidien LPGAT2015-09-02
04038653983919PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653983544PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653750337PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653750450PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653871230PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900480PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900695PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900701PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900725PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653911035PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653922246PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439000944PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439001002PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439059072PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900503PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900510PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900732PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653988402PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653951048PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900541PremicronB BRAUN SURGICAL SAGAT2015-08-26