DEVICE: StitchKit (00860088000206)

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Device Identifier (DI) Information

StitchKit
SK-002

ORIGAMI SURGICAL LLC
00860088000206
GS1
1
StitchKit ePTFE Suture Delivery Canister
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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
Polytetrafluoroethylene suture A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of expanded polytetrafluoroethylene (ePTFE) 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, used most frequently in cardiovascular surgery, provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GCJ Laparoscope, General & Plastic Surgery
NAY System,Surgical,Computer Controlled Instrument
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 26, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00860088000213 6 00860088000206 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
9737656256
info@origamisurgical.com
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