AccessGUDID - DEVICE: WoundSeal® (00834061000040)

GUDID

Device Identifier (DI) Information

Brand Name: WoundSeal®
Version or Model: CSU004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CSU004
Company Name: BIOLIFE, L.L.C.

Primary DI Number: 00834061000040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 135872476 *Terms of Use

Device Description: WoundSeal® Powder

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):	Yes
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?
47917	Non-organic haemostatic agent	A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070520	000
K080210	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, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bcf22ec2-ed7e-42ae-ba69-d6f545bc3307
Public Version Date: January 15, 2025
Public Version Number: 5
DI Record Publish Date: January 28, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00834061000248	24	00834061000040		In Commercial Distribution	Case
00834061000484	48	00834061000040		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00834061000279 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: +1 941.360.1300
Email: customer.care@biolife.com

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