AccessGUDID - DEVICE: HaloShield (00827002462908)

GUDID

Device Identifier (DI) Information

Brand Name: HaloShield
Version or Model: G46290
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-SHIELD-2.0
Company Name: COOK BIOTECH INCORPORATED

Primary DI Number: 00827002462908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945385862 *Terms of Use

Device Description: HaloShield Nipple 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?
13570	Wound shield	A mechanical shield that is designed to form a protective structure over a wound. It may be cage-like and will allow exposure to air and permit access to the injured area while protecting against accidental damage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	CATHETER, IRRIGATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905766	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
Special Storage Condition, Specify: Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2bdd4b39-0dd1-42a0-8ff8-5e720c15ae64
Public Version Date: February 19, 2025
Public Version Number: 3
DI Record Publish Date: March 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10827002462905	5	00827002462908		In Commercial Distribution

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(812)330-5494
Email: sharedservices@cookmedical.com

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