AccessGUDID - DEVICE: GELITA-SPON® STANDARD (04260293133076)

GUDID

Device Identifier (DI) Information

Brand Name: GELITA-SPON® STANDARD
Version or Model: GS-030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GELITA MEDICAL GmbH

Primary DI Number: 04260293133076
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 330774063 *Terms of Use

Device Description: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable. Its porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptive capacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes. It is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.

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?
48170	Gelatin haemostatic agent	A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYA	Splint, Intranasal Septal
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 at room temperature, keep dry and away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 80 Millimeter
Height: 10 Millimeter
Depth: 40 Millimeter

Device Record Status

Public Device Record Key: a93799fb-3517-4b55-9857-2b6802a2d744
Public Version Date: December 14, 2023
Public Version Number: 2
DI Record Publish Date: July 28, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04260293130075	10	04260293133076	2023-12-12	Not in Commercial Distribution	Suture Box
04260293137074	12	04260293130075	2023-12-12	Not in Commercial Distribution	Transport Box