DEVICE: MANI Sutures PGA (04546951403140)

Device Identifier (DI) Information

MANI Sutures PGA
2890
In Commercial Distribution
2890
MANI, INC.
04546951403140
GS1

1
690622428 *Terms of Use
MANI Ophthalmic Sutures
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
Polyglycolic acid suture A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053636 000
No 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
Device Size Text, specify: Needle Length 8.5mm
Device Size Text, specify: Suture Length 45cm
CLOSE

Device Record Status

8b4cf3e0-8dfc-4caf-928d-da192b9fc6e2
July 09, 2018
3
June 15, 2016
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
14546951403147 12 04546951403140 In Commercial Distribution
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE