DEVICE: Xclose Plus (00860323000206)

Download: XML | JSON

Device Identifier (DI) Information

Xclose Plus
XC-201-01
XC-201-01
Kr Medical Technologies LLC
00860323000206
GS1
1
TISSUE REPAIR SYSTEM WITH INVISILOC TECHNOLOGY
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polyethylene suture A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyethylene (PE), intended to join (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 can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
October 24, 2015

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
877-326-8539
customerservice@krmedtech.com
CLOSE