INDALJIMTM

Basic Information

• Brand Name: INDALJIMTM
• Primary DI: 07506561200246
• Version / Model: OV-M
• Company Name: Indaljim, S.A. de C.V.
• Labeler DUNS: 812753058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-28
• Public Version: 1
• Public Version Date: 2022-02-07
• Public Version Status: New
• Public Device Record Key: 4f663c55-a968-4ea9-a919-6e5c76adee6e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FXO	Suit, Surgical	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65414	Surgical coverall	A single-piece, fluid-resistant garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, legs, and head during a surgical procedure or for other appropriate medical reasons. Also known as a jump suit, it is used to help protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material; it may include separate shoe covers. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07506561200246	GS1