AccessGUDID - DEVICE: POLYGLYTONE 6211 (04026704603909)

GUDID

Device Identifier (DI) Information

Brand Name: POLYGLYTONE 6211
Version or Model: IPN000862
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 833-135
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704603909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Polyglytone 6211 Size 2-0 36" CST-43 Needle T Needle BSC

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57991	Polyglytone suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polyglytone 6211 (a polyester composed of glycolide, caprolactone, trimethylene carbonate, and lactide) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues, including use in ophthalmic surgery but not for cardiovascular/neurological surgery and microsurgery; 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, and is subsequently absorbed by hydrolysis. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Suture Length 36", Needle 1 Length 1.030", Needle 2 Length 0.156"

Device Record Status

Public Device Record Key: a4ac03b5-df92-427b-884f-5cea082879bd
Public Version Date: January 15, 2019
Public Version Number: 3
DI Record Publish Date: October 16, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24026704603903	12	04026704603909	2019-01-15	Not in Commercial Distribution	Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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