FDA.reportPublic FDA data

Globe

Primary DI
00850026393019
Brand
Globe
Company
Trifecta Pharmaceuticals USA LLC
Model
20202
Device description
Globe Sterile Gauze Pads 3 x 3 Box of 100
Published
2021-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026393064PrimaryGS10
00850026393019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026393064008500263930648500263930640850026393064
00850026393019008500263930198500263930190850026393019

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-296-9067info@trifecta-pharma.com

Regulatory Flags#

DUNS number
079424163
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026393064Globe 202022021-02-28
00850026393118Globe 202092021-02-28
00850026393071Globe 202062021-02-28
00850026393088Globe 202072021-02-28
00850026393095Globe 202082021-02-28
00850026393033Globe 202062021-02-28
00850026393040Globe 202072021-02-28
00850026393026Globe 202082021-02-28
00850026393002Globe 202092021-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
G242YCBJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-12
G242YCAYMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCCCMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCETMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YVBRMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCADMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAKMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCASMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBOMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCDAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YVAMMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCABMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCACMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAEMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAGMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCALMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAMMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCANMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAQMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCARMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCATMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05