FDA.reportPublic FDA data

Globe

Primary DI
00850026393071
Brand
Globe
Company
Trifecta Pharmaceuticals USA LLC
Model
20206
Device description
Globe Non-Adherent Pads 3 x 8 Box of 50
Published
2021-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850026393071PrimaryGS10
00850026393033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026393071008500263930718500263930710850026393071
00850026393033008500263930338500263930330850026393033

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079424163
Device count
50
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026393064Globe 202022021-02-28
00850026393118Globe 202092021-02-28
00850026393088Globe 202072021-02-28
00850026393095Globe 202082021-02-28
00850026393019Globe 202022021-02-28
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
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06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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