AccessGUDID - DEVICE: Premium Polysorb (10884521047570)

GUDID

Device Identifier (DI) Information

Brand Name: Premium Polysorb
Version or Model: 013501L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 013501L
Company Name: Covidien LP

Primary DI Number: 10884521047570
Issuing Agency: GS1
Commercial Distribution End Date: May 29, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Loading Unit with Polysorb Staples

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?
45027	Soft-tissue/mesh anchor, bioabsorbable	A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GDW	STAPLE, IMPLANTABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K830199	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
Height: .060 Inch
Length: 55 Millimeter

Device Record Status

Public Device Record Key: d463f46d-4ec5-4220-b404-8dd5272c01fd
Public Version Date: June 24, 2025
Public Version Number: 8
DI Record Publish Date: August 28, 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
20884521047577	6	10884521047570	2020-05-29	Not in Commercial Distribution	CASE

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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