FDA.reportPublic FDA data

GEM™ Wound Dressing Foam

Primary DI
10850001118207
Brand
GEM™ Wound Dressing Foam
Company
LYNCH BIOLOGICS, LLC
Model
LBWDF
Device description
Dental Wound Dressing Foam, 2cm x 4cm x 3mm
Published
2018-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001118207PrimaryGS10
00850001118200Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000111820710850001118207
00850001118200008500011182008500011182000850001118200

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, animal-derivedA collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Millimeter
Length2Centimeter
Width4Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079604282
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001118088GEM™ Bone GraftLBNB05102018-10-18
00850001118095GEM™ Bone GraftLBNB10102018-10-18
00850001118101GEM™ Bone GraftLBNB20102018-10-18
00850001118118GEM™ Bone GraftLBNB40102018-10-18
00850001118125GEM™ Bone GraftLBNB10202018-10-18
00850001118132GEM™ Bone GraftLBNB20202018-10-18
00850001118149GEM™ Bone GraftLBNBS0252018-10-18
00850001118156GEM™ Bone GraftLBNBS052018-10-18
10850001118191GEM™ Wound Dressing TapeLBWDT2018-10-18
10850001118214GEM™ Wound Dressing PlugLBWDP2018-10-18
00850001118019GEM Adapt™LBADAPT15202018-10-18
00850001118026GEM Adapt™LBADAPT20302018-10-18
00850001118033GEM Adapt™LBADAPT30402018-10-18
00850001118040GEM Extend™LBEXT15202018-10-18
00850001118057GEM Extend™LBEXT20302018-10-18
00850001118064GEM Extend™LBEXT30402018-10-18
00850001118071GEM Cap™LBCAP12162018-10-18
00850001118163GEM™ Synthetic Bone GraftLBSB0502018-10-18
00850001118170GEM™ Synthetic Bone GraftLBSB1002018-10-18
00850001118187GEM™ Synthetic Bone GraftLBSB2002018-10-18

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Primary DI, Brand, Company table
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09421908222669Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
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09421908222690Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
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