AccessGUDID - DEVICE: UNIFY PTFE Surgical Sutures (00814639024845)

GUDID

Device Identifier (DI) Information

Brand Name: UNIFY PTFE Surgical Sutures
Version or Model: XXL-F230K60
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APPLIED DENTAL, INC.

Primary DI Number: 00814639024845
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017524666 *Terms of Use

Device Description: PTFE Sutures, Non-absorbable, 2-0, monofilament, 60mm straight needle, 30"

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):	No
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?
17245	Polyester suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic thread made from a non-bioabsorbable polyester (e.g., polybutester) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170842	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1c7285d-e32e-426a-b1fe-ddc44454b30f
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: August 06, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10814639024842	12	00814639024845		In Commercial Distribution	Box
20814639024849	100	10814639024842		In Commercial Distribution	Carton

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: 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-841-8481
Email: info.usa@AD-Surgical.com

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