AccessGUDID - DEVICE: Responder® Polysaccharide Hemostat (00899010002889)

GUDID

Device Identifier (DI) Information

Brand Name: Responder® Polysaccharide Hemostat
Version or Model: RP0025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Starch Medical Inc.

Primary DI Number: 00899010002889
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020462087 *Terms of Use

Device Description: RESPONDER® Polysaccharide Hemostat is intended to be used to achieve hemostasis in emergency situations forthe temporary control of severe topical bleeding.

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?
38771	Plant polysaccharide haemostatic agent, bioabsorbable	A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.	Active	true

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 [?]
K220525	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: ec181c95-916d-4709-8f28-7b4e6ca16db7
Public Version Date: June 11, 2024
Public Version Number: 1
DI Record Publish Date: June 03, 2024