AccessGUDID - DEVICE: SurgiSleeve (30884521164813)

GUDID

Device Identifier (DI) Information

Brand Name: SurgiSleeve
Version or Model: WPLG914
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 30884521164813
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Large Wound Protector

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?
47431	Radial surgical retractor	A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and internal fixed or retracting ring interconnected with an elastomeric sleeve/sheath intended to also provide protection against wound contamination, and may include channels/tubing to allow wound-edge irrigation. Also known as a lap disc, hand access device, handport, or protector, it may be used with or without a seal cap for colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCI	LARYNGOSCOPE, ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120061	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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: less than 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ef9330e-954e-4623-b2fd-d5ee0f1d4e75
Public Version Date: August 01, 2025
Public Version Number: 8
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521164816	5	10884521164819		In Commercial Distribution	PACK_OR_INNER_PACK
10884521164819	12	30884521164813		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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