AccessGUDID - DEVICE: Sterile PTFE Surgical Suture (08056646503018)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile PTFE Surgical Suture
Version or Model: 32.Z4400.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OMNIA SRL

Primary DI Number: 08056646503018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 447696675 *Terms of Use

Device Description: PTFE Suture 60 cm - 3/0 - 19 mm Needle 3/8 - Body Reverse Cutting

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":	No
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?
17467	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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: KEEP AWAY FROM SUNLIGHT AND KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63deb308-679f-4243-840d-2cc7943426f1
Public Version Date: December 21, 2018
Public Version Number: 3
DI Record Publish Date: February 27, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 08056646503001 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +390524527453
Email: info@omniaspa.eu

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