DEVICE: SubQ It! (00867469000213)

Device Identifier (DI) Information

SubQ It!
SF10
In Commercial Distribution
408010
OPUS KSD, INC.
00867469000213
GS1

1
965571289 *Terms of Use
SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34606 Skin stapler/staple, bioabsorbable
A hand-held manual surgical instrument, preloaded with bioabsorbable skin staples, designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of material(s) that are gradually degraded and absorbed by the body (typically biodegradable polymer). This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GDW Staple, Implantable
GAG Stapler, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131563 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d1263f9d-2761-458e-aea0-3201ee36954a
March 10, 2021
3
July 29, 2019
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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
10867469000210 10 00867469000213 In Commercial Distribution Shelf Box
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Secondary DI

[?]
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
Yes
No CLOSE

Customer Contact

[?]
3399338811
rob@subq-it.com
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