FDA.reportPublic FDA data

BGEcare

Primary DI
00810116271825
Brand
BGEcare
Company
Boston Bgecare Inc
Model
Island Dressing
Device description
Island Dressing 4"x4", 1 pc/pouch, 50 pcs/box,12 boxes/carton
Published
2023-11-20
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

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116271825PackageGS150In Commercial Distribution
00810116271818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116271825008101162718258101162718250810116271825
00810116271818008101162718188101162718180810116271818

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056757726
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00810116271818BGEcareIsland Dressing2023-11-20
00850006820009BGEcare2023-11-20
00850006820016BGEcare2023-11-20
00850006820023BGEcare2023-11-20
00850006820030BGEcare2023-11-20
00850006820047BGEcare2023-11-20
00850006820054BGEcare2023-11-20
00850006820078BGEcare2023-11-20
00850006820085BGEcare2023-11-20
00850006820092BGEcare2023-11-20
00850006820108BGEcare2023-11-20
00850006820115BGEcare2023-11-20
00850006820122BGEcare2023-11-20
00850006820139BGEcare2023-11-20
00850006820146BGEcare2023-11-20
00850006820153BGEcare2023-11-20
00850006820061Zhende2023-11-18
00850006820252zhende2023-11-19
00850006820276BGEcare2023-11-19

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Primary DI, Brand, Company table
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04260223630231curea P1curea medical GmbHNAC2026-09-27
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04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
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04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
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04260223631184curea P1 DUO activecurea medical GmbHNAC2026-09-27
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04260223631368curea P1curea medical GmbHNAC2026-09-27
04260223631672curea P2curea medical GmbHNAC2026-09-27
04260223631696curea P2curea medical GmbHNAC2026-09-27
04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
04260223631795curea P2 activecurea medical GmbHNAC2026-09-27
04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
04260223631931curea P1 easy bordercurea medical GmbHNAC2026-09-27
00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04