DEVICE: Henry Schein (00304040000236)

Device Identifier (DI) Information

Henry Schein
100-7773
In Commercial Distribution
100-7773
HENRY SCHEIN, INC.
00304040000236
GS1

1
012430880 *Terms of Use
SUT.5-0 POLYSTR GRN 18"/D-14
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
Polyester suture A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAT SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: N/A
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b752f602-cd43-4f72-b750-538ed716c847
March 29, 2018
2
September 25, 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
20304040000230 12 00304040000236 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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE