What is FDA product code OOD?

To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.

General & Plastic Surgery › ProstheticSurgical Film

GalaFORM 3d

Name: GalaFORM 3D
Brand: GalaFORM 3D

GalaFORM 3D is a bioresorbable surgical mesh that supports and reinforces soft tissue where weakness or a defect requires additional material. It is used in plastic and reconstructive…

Registry build 21.09.26

GalaFORM 3D is a bioresorbable surgical mesh that supports and reinforces soft tissue where weakness or a defect requires additional material. It is used in plastic and reconstructive surgery, general soft tissue reconstruction and repair of fascial defects.

The scaffold is made from poly-4-hydroxybutyrate and has a three-dimensional curve supported by a rim of the same polymer. The rim provides a stiffer edge to help the mesh conform where a flat design may be unsuitable.

Listed Item

GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient’s anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months.

Tissue Support

The porous structure permits tissue ingrowth as the scaffold gradually loses strength and transfers load to the tissue. The polymer breaks down through hydrolysis and enzymatic digestion. The mesh is sterilized with ethylene oxide and intended for single use.

1manufacturer

13catalogue numbers in this listing

11510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Fujian.

Chinese manufacturers registered for FDA product code OOD
Manufacturer	City	Province	Registered as	Device types
Xiamen MK Health Care Product Co., Ltd.	Xiamen	Fujian	Manufacturer	7

Record

Regulatory record for GalaFORM 3D
Listed by	Tepha, Incorporated, United States
FDA product code	OOD
Device type	Surgical Film
Device class	Class 2
Regulation	21 CFR 878.3300
Establishment	Specification developer, Manufacturer
510(k)	K162922
Record published	2017-05-01
Record revised	2025-09-17 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Sizes	Height 2.5 to 7.6 cm; length 7.6 to 21 cm; outer diameter 7.6 cm
Distribution end date	2020-09-25

Catalogue Numbers

Catalogue numbers for GalaFORM 3D
Catalogue number	Size	Status
100043-03	Height 6.4 cm	Withdrawn
100043-07	Height 7.6 cm	Withdrawn
100043-11	Length 10.2 cm	Withdrawn
100043-02	Length 15.5 cm	Withdrawn
100043-10	Height 2.5 cm	Withdrawn
100043-04	Length 18.5 cm	Withdrawn
100043-14	Outer Diameter 7.6 cm	Withdrawn
100043-12	Height 2.5 cm	Withdrawn
100043-01	Height 5.3 cm	Withdrawn
100043-09	Length 7.6 cm	Withdrawn
100043-13	Outer Diameter 7.6 cm	Withdrawn
100043-06	Length 21 cm	Withdrawn
100043-05	Height 7.5 cm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Phasix	Davol Inc.	37
GalaFLEX Scaffold	Tepha, Incorporated	14
GalaFLEX Lite	Tepha, Incorporated	14
GalaFLEX 3D	Tepha, Incorporated	14
GalaSHAPE 3D	Tepha, Incorporated	14
GalaFLEX Lite	Davol Inc.	13
GalaFLEX 3DR	Tepha, Incorporated	13
GalaFLEX 3D	Davol Inc.	7
GalaFLEX 3DR	Davol Inc.	6
GalaFLEX	Davol Inc.	5
Gelfilm	Pharmacia & Upjohn Company LLC	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233999	2024-04-09
K202425	2021-08-19
K162922	2017-02-23
K161092	2016-08-23
K140533	2014-05-21
K130326	2013-05-07
K113723	2012-02-15
K113721	2012-02-15
K111946	2011-09-26
K091633	2009-08-07
K070894	2007-04-13

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-11-21	Class II	Process design	Endotoxin values from testing of retains slightly exceeded the established specification.	29	2017-01-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.