AccessGUDID - DEVICE: GalaFLEX 3D (00810054980315)

GUDID

Device Identifier (DI) Information

Brand Name: GalaFLEX 3D
Version or Model: 100042-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SH3D06
Company Name: Tepha, Inc.

Primary DI Number: 00810054980315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039856765 *Terms of Use

Device Description: GalaFLEX 3D Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 2)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OOD	Surgical Film

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161092	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 7.5 Centimeter
Length: 21.0 Centimeter

Device Record Status

Public Device Record Key: 36cd3917-96c5-40ee-aac8-22a0122ef3b6
Public Version Date: October 22, 2024
Public Version Number: 5
DI Record Publish Date: September 29, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: 781-357-1750
Email: contact@galateasurgical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES