FDA.reportPublic FDA data

Globe

Primary DI
00850026393118
Brand
Globe
Company
Trifecta Pharmaceuticals USA LLC
Model
20209
Device description
Globe Sterile Gauze Pads 4 x 4 Box of 100
Published
2021-02-28
Public version status
Update
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
00850026393118PrimaryGS10
00850026393002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026393118008500263931188500263931180850026393118
00850026393002008500263930028500263930020850026393002

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, non-antimicrobialA non-medicated 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.

Contacts#

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

Regulatory Flags#

DUNS number
079424163
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026393064Globe 202022021-02-28
00850026393071Globe 202062021-02-28
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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